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FRIDAY, MARCH 11, 201 1VOL. 15, NO. 43 PAGE 1 OF 10 Large firm mantra; growth comes by any M&A possible By OMAR FORD Medical Device Daily Staff Writer Large med-tech companies will have to continue to look toward M&A activities to supplement slower organic growth in mature markets, according to The Walden Group’s (Tarrytown, New York), 2010 report. The 30-page document, which includes acquisitions in the medical device sector, highlights seven key deals or those transactions with a value of more than $100 million. Richard Cohen, president of The Walden Group, a strategic investment banking firm for the healthcare industry, spoke to Medical Device Daily earlier this week about some of the highlights of the report. “The larger medical device companies have product lines that are addressing markets that are flattening,” Cohen said. “They’re under price pressure. So they’re seeing huge See Walden, Page 6 FDA advisory committee Former deputy commissioner alleges bias at gene test panel By MARK McCARTY Medical Device Daily Washington Editor GAITHERSBURG, Maryland – FDA called a meeting of the molecular and clinical genetics advisory committee to go over the issue of direct-to-consumer gene testing services, a topic that was sure to generate controversy given the goings-on in a hearing on Capitol Hill last year. However, a former deputy FDA commissioner added to the mix with allegations that FDA had set up the meeting’s first day in such a way as to stack the deck against companies that offer DTC gene testing services. All the same, the panel sided with FDA in fairly clear terms on the question of whether a prescription should be required for tests of a patient’s genetic predisposition toward a disease state despite accusations of medical See Advisory, Page 7 European Congress of Radiology Washington roundup Merging MRI with PET Siemens Senate passes patent reform challenged to prove clinical case as House addresses case law By JOHN BROSKY Medical Device Daily European Editor VIENNA – If you think airport scans are revealing, wait until you see your PET-MRI image. For the first time, Siemens has joined PET with magnetic resonance imaging (MRI) for simultaneous acquisition. It is a staggering feat of engineering that produces stunning whole body images illuminating metabolic processes taking place in vivo and in real time. The clinical value of PET is well-established in CT with 3.2 million exams ordered up last year worldwide. But even software-enhanced CT images pale against the sharp details and soft-tissue contrast of MRI from the new Biograph mMR shown during the radiology congress See ECR, Page 8 By MARK McCARTY Medical Device Daily Washington Editor The U.S. Senate finally passed a patent reform bill by a blow-out margin of 95-5, a sign that the Senate takes patent reform seriously, but also a signal that other considerations no longer trump purely economic considerations. However, the House Judiciary Committee held a hearing yesterday to examine the current state of case law in an effort to flesh out which issues remain to be addressed via legislation, hinting that a HouseSenate conference will be needed to reconcile what are almost certain to be two fairly different bills. Meanwhile, the House is also considering a bill that would change medical research tax policy, the American Research and See Washington, Page 9 Don’t miss today’s MDD Extra: Diagnostics INSIDE: MEDTRONIC OPENS NEW FACILITY IN SINGAPORE TO MEET ASIA DEMAND ..................... 2 VENITI RAISES $13.5 MILLION IN SERIES A FUNDING .......................................... .3 To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 888-3912; outside the U.S. and Canada, call (404) 262-5547. Copyright © 2011 AHC Media. Reproduction is strictly prohibited. Visit our web site at www.medicaldevicedaily.com. Staff Writers: Omar Ford.medicaldevicedaily. and Canada. said at the opening ceremony. The company said the new facility will help enhance its manufacturing capabilities to meet the future expected growth of cardiac devices in Asia. LLC company. “The completion of Medtronic’s first pacemaker and leads manufacturing facility in Asia marks an important milestone in Medtronic’s ever growing presence in Singapore. mentioned that Medtronic Singapore Operations will have hired and trained more than 120 staff by the end of the year as production increases to meet the growing demand. which is being closed. The Cardiac Rhythm Disease Management business at Medtronic accounted for $5.vance@ahcmedia. 1. For photocopy rights or reprints. Johnston. education centers and administration facilities which serve customers and patients in 120 countries. Building Six. (404) 262-5540 Amanda Pedersen. (404) 262-5439 INTERNET www. a subsidiary. and Canada. research centers. Visit our web site at www. Bob Sobel. executive VP and group president of Medtronic International. During 2010 STAAR generated $1. the company noted. “That is why our manufacturing investment in Singapore is so important. (GST Registration Number R128870672) ATLANTA NEWSROOM: Managing Editor: Holland Johnson. REPRINTS: To subscribe.A. Account Representatives: Scott Robinson. EST. sales offices. please call MEDICAL DEVICE DAILY™ Customer Service at (800) 888-3912.” – Richard Cohen.” pp. MEDICAL DEVICE DAILY™ is a trademark of AHC Media. In his opening address at the ceremony. GA 30305. The bar is now raised for companies to make acquisitions. Singapore will also serve as the distribution hub for the Asia-Pacific region. 6. (404) 262-5451 SVP/GROUP PUBLISHER Donald R. a Thompson Media Group. on the increasing likelihood of more blockbuster deals in the med-tech sector going forward. Medtronic says it will have invested more than $56 million to the development of its MSO to meet the rising demand in Asia.S. STAAR in distribution with Ellex in Australia STAAR Surgical (Monrovia.FRIDAY. Page 5 SUBSCRIBER INFORMATION Please call (800) 888-3912 to subscribe or if you have fax transmission problems. We expect its expertise and reputation to improve our market reach See International. Chris Wiley. BUSINESS OFFICE: Senior Vice President/Group Publisher: Donald R. growth comes by any M&A possible.com. which began operations in January.m. Amanda Pedersen. Product Marketing Manager: Sarah Cross. needs of patients and physicians and are leveraging all of our global capabilities to address this growing epidemic. “We are very pleased to be partnering with Ellex and to have our products join the Ellex portfolio. (309) 351-7774 Omar Ford. Medtronic Singapore Operations (MSO). improving standards of care in Asia. . Jean-Luc Butel.m. The new facility. will enable Medtronic to respond more effectively and efficiently to the needs of customers and patients with cardiac rhythm disorders. Our customer service hours are 8:30 a. As of November 2011. outside the U.” The Medtronic Singapore Operations is added on to Medtronic’s stable of more than 250 manufacturing facilities. EDITORIAL Holland Johnson. Mention of products or services does not constitute endorsement. 201 1 MEDICAL DEVICE DAILY™ PAGE 2 OF 10 International report Medtronic opens new facility in Singapore to meet Asia demand A Medical Device Daily Staff Report Medtronic (Minneapolis) reported the official opening of its new manufacturing facility.com. Ellex will market STAAR’s Visian ICL line of refractive lenses.medicaldevicedaily. (404) 262-5546 Mark McCarty. Singapore’s Minister for Trade & Industry. We now have greatly increased our ability to ensure Medtronic’s innovative medical technologies will help patients across emerging Asian markets. Medtronic’s investment is a strong vote of confidence for our efforts in developing Singapore into a leading biomedical sciences hub. No part of this publication may be reproduced without the written consent of AHC Media. we understand well the MDD’s food for med-tech thought “I think there will [continue to] be large transactions. call (404) 262-5547. Senior Production Editor: Rob Kimball. By the end of 2011.2 billion of the company’s revenue in the 2010 financial year. Reproduction is strictly prohibited. All Rights Reserved.S. California) said it has entered into an agreement with Ellex Australia (Adelaide) for the exclusive distribution of STAAR intraocular lenses in Australia.” Lim Hng Kiang.000 in net income. (703) 268-5690 Rob Kimball. Johnston. 3525 Piedmont Road.com MEDICAL DEVICE DAILY™ (ISSN# 1541-0617) is published every business day by AHC Media. Copyright © 2011 AHC Media.” said Medtronic CEO William Hawkins.S. to 6:00 p. MARCH 11. “As a leader in the management of cardiovascular and other non-communicable diseases. president of The Walden Group. Washington Editor: Mark McCarty. Suite 400. “Large firm mantra. Copyright © 2011 AHC Media. Atlanta.7 million in sales from the region through a direct team of five employees and generated about $200. Opinions expressed are not necessarily those of this publication. STAAR’s intraocular lenses for cataract patients and related products. Director of Product Management: Jane Cazzorla. call (404) 2625547. STAAR has previously distributed its products in the region through ConceptVision Australia. Outside U. please call Stephen Vance at (404) 262-5511 or e-mail him at stephen. U. please call MEDICAL DEVICE DAILY™ Customer Service at (800) 888-3912. • Nephros (River Edge. were also significant participants in the new financing and NeoMed retains its role as the lead investor and largest shareholder of NovaShunt. . IDE study of the technologies in peripheral artery disease in the first half of 2011. In other financings activity: • NovaShunt (Zug. sometimes weekly or bi-weekly. Existing investors. MARCH 11. infection control. reported that it has raised $25 million in a Series B preferred share financing round co-led by BioMedInvest. in patients suffering from liver cirrhosis. Foundation Medical Partners and Michael Berman.3 million. BridgePoint Medical’s CrossBoss Catheter and Stingray System are uniquely designed to facilitate guidewire placement and subsequent dilatation balloon or Drug Eluting Stent (DES) placement in this challenging anatomy.FRIDAY. and a stent system designed specifically for treating this complex disease.S. In order to treat a CTO patient with minimally invasive therapy.125% senior notes due 2021. Baird Venture Partners. the repayment of the $500. Additionally. BridgePoint Medical will be initiating a U. Nephros’ largest stockholder. The round was lead by a new strategic investor and joined by existing investors New Enterprise Associates. Visit our web site at www. known as ascites. Refractory ascites occurs when patients with excess ascites no longer respond to medical therapy and it affects over 100. certain cancers and congestive heart failure. and Canada. a vena cava filter anchoring technology. in September 2010 in connection with its loan to Nephros. call (404) 262-5547. a private company developing technology in the field of interventional cardiology for crossing coronary and peripheral chronic total occlusions (CTO). California). Polaris Venture Partners. The Veniti platform will offer medical professionals a comprehensive solution for treating venous disease. Europe and Japan through the use of distributors and direct sales. NovaShunt’s ALFApump System is a proprietary. the common alternative is bypass surgery or palliative care. • Medtronic (Minneapolis) reported a registered offering of $500 million of its 2. totaling $9. the standard therapy for patients with refractory ascites. The cumulative cost of repeat paracentesis for these patients often exceeds $25.000 for reimbursement of Lambda Investors’ legal fees incurred in connection with the loan and the rights offering. H&Q Healthcare Investors and H&Q Life Sciences Investors led the round. Switzerland). See Financings.5 million in Series A financing.1 million. and were joined by Prolog Ventures. the payment of an 8% sourcing/transaction fee ($40. Veniti will augment its product portfolio by acquiring two separate medical device companies.S. The number of patients suffering from ascites is growing due to the accelerating incidence of hepatitis and obesity-related liver disease (NAFLD). 201 1 MEDICAL DEVICE DAILY™ PAGE 3 OF 10 Financings roundup Veniti raises $13. Louis Arch Angels and a number of individual investors. Entrepreneurs Fund and Capricorn Health-tech Fund. The company is currently completing enrollment in the PIONEER Study. a physician must first successfully cross the blockage and place a guidewire beyond the occlusion. reported that it has completed its third round of financing. after deducting the estimated aggregate expenses of these transactions. The proceeds will be used to acquire two additional medical device companies and begin commercialization of multiple products singularly focused on treating chronic venous disease. Initial products are expected to be available in late 2011. California) and Teneo Medical Development (Fremont. open label study designed to evaluate the safety and performance of the ALFApump System in obviating the need for paracentesis.2 million to Nephros..000) in respect of the note and an aggregate of $100. to remove between 510 liters of accumulated ascites. every year. unsecured obligations of Medtronic and will rank equally with all of Medtronic’s existing and future senior. which may include repayment of its indebtedness. unsecured debt and senior to all of Medtronic’s subordinated debt. plus all accrued interest thereon. including a vapor-based endovenous ablation system.5M in Series A funding A Medical Device Daily Staff Report Veniti (St. outside the U.S. The notes will be senior. a prospective. Varix Medical (Sunnyvale.000 patients in Europe and the U. The Series C financing will be used to enable marketing and sales efforts for BridgePoint’s CrossBoss Catheter and Stingray System in the U.000 note.com. Interventional cardiologists are currently unable to broadly treat patients with chronic total occlusions which comprise approximately one third of all patients with coronary artery disease and approximately one half of patients with peripheral artery disease. a private Swiss company that develops fluid management technologies. reported the completion of its rights offering and private placement that together resulted in gross proceeds of nearly $3.S. multi-center. The aggregate net proceeds received by Nephros from the rights offering and private placement are estimated to be about $2. For these patients. Paracentesis is a procedure in which a large bore needle is inserted into the patient’s abdomen.625% senior notes due 2016 and $500 million of its 4. implantable pump system that continually removes excess abdominal fluid. Page 6 To subscribe. Medtronic intends to use the net proceeds for working capital and general corporate purposes. NeoMed and VI Partners. issued to Lambda Investors. Reproduction is strictly prohibited.medicaldevicedaily.000 each year. Concurrent with this investment. • BridgePoint Medical (Minneapolis). Copyright © 2011 AHC Media. and water purification. St. Louis) reported it has raised $13. New Jersey) a company that develops filtration products for therapeutic applications. outside the U.” said Atlantic Health chief supply chain officer and director of orthopedic services Joseph DiPaolo. that will deliver accurate. “We appreciate the flexibility of its purchasing contracts and how easily MedAssets’ solutions align with our specific needs. reported that it has acquired Star Infusion and Compression (Grosse Ilse. New Jersey) has signed a multi-year contract extension with MedAssets (Alpharetta. and training on use of the products. The Mind Mouse interfaces a person’s brain with a wireless EEG type headset to a computer. is not expected to materially impact the company’s fiscal 2011 consolidated financial performance.FRIDAY. This agreement is expected to expand to other applications that the company is developing at this time. Michigan). Michigan). Atlantic Health has also realized more than $7.com. ■ Deals roundup InfuSystem Holdings in move to acquire SIC A Medical Device Daily Staff Report InfuSystem Holdings (Madison Heights. This neural processing technology makes it possible for computers to interact directly with the human brain. To engage clinicians in the cost reduction process. Reproduction is strictly prohibited. to provide an integrated platform to advance the identification and validation of new drug targets and improve assessment of drug response. the distributorship will include storage.1 billion. In other agreements/contracts news: • Caliper Life Sciences (Hopkinton.” The acquisition. • Mind Technologies (Cardiff. and reproducible measurements of proteins in tissue samples. and Canada. . a provider of infusion pumps and related services. HistoRx’s proprietary image analysis system.S. Star Infusion is a provider of ambulatory infusion pumps and related services to oncologists in Michigan and Ohio. ■ To subscribe. marketing. The health system realized more than $13 million in supply chain savings using MedAssets’ technology and services. Sean McDevitt. Atlantic Health uses MedAssets for strategic sourcing or group purchasing services. The health system also uses Strategic Information and Strategic Information for Pharmacy to increase visibility into supply chain and pharmacy purchasing and to identify savings opportunities. “Star Infusion has developed a loyal customer following and we welcome those oncology practices and their patients to InfuSystem.medicaldevicedaily. completely hands free without the use of speech or manual controls. 201 1 MEDICAL DEVICE DAILY™ PAGE 4 OF 10 Agreements/contracts MedAssets gives supply support to Atlantic Health A Medical Device Daily Staff Report Atlantic Health (Summit. supply chain technologies and analytics solutions.5 million in managed care recoveries over several years through the use of MedAssets’ revenue cycle services to accelerate its cash flow and improve margins. Copyright © 2011 AHC Media. including e-mail and web browsing. 154 licensed beds within its two hospitals and reported more than 62. Georgia) for supply chain and clinical resource management services. an automated multiplexed tissue imaging platform. quantitative. allowing the user to interact with the computer and other machines through the power of the mind.” Atlantic Health has 1 . Mind Technologies makes software for thought controlled technologies. HistoRx makes tissue-based diagnostic solutions. Massachusetts) and HistoRx (Branford. We are very pleased with the synergies this acquisition provides and it further solidifies and enhances InfuSystem’s leading national position in the ambulatory infusion market. and Aqua technology. which was for cash. chairman/CEO of InfuSystem. allowing any medically handicapped individual to operate all functions. which detects brainwaves on both the conscious and non-conscious level. California) has signed a distribution and marketing agreement for the company’s medical applications. call (404) 262-5547. sales.000 patient admissions in 2010 with net patient revenue of $1. Further details of the acquisition were not disclosed. the agreement will cover the marketing of Mind Mouse and the company’s new proprietary headset. based on immunofluorescence. Caliper Life Sciences makes diagnostic tests. Initially. The technology involves the use of a wireless headset. MARCH 11. Connecticut) reported a collaboration to co-develop a new generation of tissuebased imaging and analysis solutions. Atlantic Health says it relies on MedAssets’ webbased service line analytics tool and clinical consulting services to analyze clinical and financial performance across its service lines and identify variations in clinical resource use. Caliper will have exclusive worldwide distribution rights for the integrated product in the life sciences research market as the companies continue to explore additional collaborative opportunities in clinical research and diagnostics. said. please call MEDICAL DEVICE DAILY™ Customer Service at (800) 888-3912. Their ability to drive physician engagement through expert clinical consulting and state-of-the-art analytics and technology is really helping us move the needle across our system when it comes to high-cost supply items. The collaboration will enable researchers to leverage the combined imaging and analysis power of Caliper’s Vectra. “MedAssets has been an important partner for us in formulating and executing a supply chain cost reduction strategy. In addition under the agreement. MedAssets partners with healthcare providers to improve financial strength by implementing spend management and revenue cycle management solutions. Visit our web site at www. ” The five Methodist facilities implementing HealthView are: Methodist Heart Hospital. a general surgeon.” “We believe with Ellex’s presence in the region. iCarePassport includes outcomes modules that patients can easily complete online which will provide OASIS information critical to monitoring and measuring evidence-based quality outcomes. during. and Methodist Stone Oak Hospital.medicaldevicedaily. To provide the basis for the medical position statement. which includes information affirming the utility of RFA therapy as a treatment option for eradication of Barrett’s esophagus. a web-based electronic medical records (EMR) system for physical therapists. California). more affordable. To subscribe. Linking the patient’s care journey from pre-admission through the hospital stay and recovery at home. Visit our web site at www.” ■ Med-Tech Notes Guidelines confirm RFA for BE treatment Barrx Medical (Sunnyvale. The technical review was submitted to a medical position panel consisting of a diverse group of stakeholders. and after a surgical procedure.com. Methodist Children’s Hospital. 201 1 MEDICAL DEVICE DAILY™ PAGE 5 OF 10 HIT roundup San Antonio heart attack patients benefit from HealthView solution A Medical Device Daily Staff Report Lumedx (Oakland. Methodist Specialty and Transplant Hospital. Copyright © 2011 AHC Media. WebPT said it is officially launching the program with two of the industry’s most widely used physical therapy billing solutions. president/CEO of Methodist Healthcare. the Orthopedic and Spine Inpatient Surgical Hospital (OASIS.” said Jaime Wesolowski. Methodist hospitals will use HealthView to make pre-hospital and emergent electrocardiographs (ECGs) immediately available to cardiologists for interpretation. “This technology will take us to a new level of cardiac care. such as radiofrequency ablation (RFA) technology as delivered by the Barrx HALO Ablation System. more efficient billing processes for PT clinics. CFO of STAAR. The guideline recommends removal of precancerous cells in patients with confirmed high-grade Barrett’s esophagus using endoscopic eradication therapy. In other HIT news: • Skylight Healthcare Systems (San Diego) reported that one of its newest clients. “Methodist Healthcare hospitals see the majority of cardiac patients in the region and these patients will be the beneficiaries of this new technology. outside the U. thereby accelerating appropriate diagnoses and improving patient care. and Canada. The medical position statement was then created.” said Don Todd.000. The integration of its fully Web-based EMR system with these popular billing solutions means smoother. said it has begun implementing the HealthView Chest Pain Management solution at five Methodist Healthcare facilities in San Antonio. Methodist Metropolitan. and more efficient for today’s mobile PT. ■ International Continued from Page 2 in Australia and New Zealand. Phoenix) has elected to maximize their use of the Skylight Access system by launching the iCarePassport application to improve the quality of patient care before. STAAR’s president of the Asia Pacific Region. please call MEDICAL DEVICE DAILY™ Customer Service at (800) 888-3912. She added that Ellex will also be purchasing during the first quarter the current inventory of product in Australia for about $400. according to the company. a provider of cardiovascular imaging and information systems (CVIS). and a consumer/patient advocate. reported a new certified billing partner program. a maker of minimally invasive medical devices to remove precancerous tissue from the gastrointestinal tract. California). including gastroenterologists. Kareo and BMS. Reproduction is strictly prohibited. Texas.S. a technical review of the literature was conducted to explore a series of questions regarding management of Barrett’s esophagus. Virginia Mason Medical Center (Seattle) is currently using the same system. The unique focus of OASIS will be the treatment of inpatient musculoskeletal surgical cases. according to Lumedx. iCarePassport will extend the benefits of Skylight Healthcare’s Access Interactive Patient Care System and the wealth of inpatient services it provides to OASIS patients. . a pathologist. The HealthView Chest Pain Management solution will be deployed at San Antonio Methodist hospitals to more closely connect emergency medical services.FRIDAY. the company noted. MARCH 11. call (404) 262-5547. a health plan representative. emergency departments and cardiovascular service lines. reported that the American Gastroenterological Association (AGA) has issued the AGA Medical Position Statement on the Treatment of Barrett’s Esophagus. HealthView Chest Pain Management system bridges emergency and cardiac medicine. review. Additionally. laboratory information and other crucial patient data. we should be able to drive additional sales and higher profits from this territory over time.” said Deborah Andrews. • WebPT (Phoenix). and immediate comparison with previous ECGs. “The Ellex organization will start highlighting STAAR products at the Asia Pacific Academy of Ophthalmology (APAO) meeting in Sydney starting on March 21. By integrating current and historical clinical information from disparate systems into a single view available anywhere with an internet connection. WebPT has already made electronic PT documentation easier. and represents a great leap forward in the care of chest pain patients. “The largest deal here in terms of size was the Novartis/ Alcon deal. . but is not yet approved by the FDA.” he said. Massachusetts) also made the list with its purchase of ev3 (Plymouth. including: increased commercial capability to accelerate sales growth and customer support. California) acquisition. the Symplicity catheter system.S.I think they quote – 70% or so of eye conditions .FRIDAY. greater patient and market access to advanced technologies.com. Novartis said that the merger of the two organizations was expected to yield a number of benefits to the company and its customers. Nephros issued to Lambda Investors an aggregate of 60. its Novartis because it does reflect certain underlying trends. ■ Financings To subscribe. 201 1 MEDICAL DEVICE DAILY™ PAGE 6 OF 10 Continued from Page 1 portions of revenue . The acquisition puts Boston Scientific firmly into the TAVI market where it goes head to head with Medtronic (Minneapolis) and Edwards LifeSciences (Irvine.2 million in gross proceeds from its sale of units to Lambda Investors. It keeps [Boston Scientific] in the game. addresses uncontrolled hypertension through renal denervation. Minnesota) for $2. “I’m not sure it’s a game changer. .” One of the largest and most important deals of last year was when Novartis (Basel. which consists of a stent-mounted tissue valve prosthesis and catheter delivery system for guidance and placement of the valve.” ■ Omar Ford. but that doesn’t necessarily mean there will be deals for the sake of big deals.com Continued from Page 3 Simultaneously with the closing of the rights offering. Switzerland) acquired Nestle’s (Veve.6 billion (MDD. call (404) 262-5547. expanded ability to develop eye care products that reach the market faster. The company recently completed a series of European feasibility studies for its Lotus valve system. It was required of them. [Boston Scientific] would be a company without a critical treatment that is getting a lot of attention. Reproduction is strictly prohibited. Nephros received nearly $1. . Cohen told MDD that both were equally important and brought new dimensions to markets.194. Additional payments of up to $193 million are contingent upon achievement of specified regulatory and revenue-based criteria through 2016. .226 units at the same per unit purchase price of 2 cents.” he said. Covidien (Mansfield. 404-262-5546. enhanced product development and branding opportunities in contact lenses and solutions. California). pursuant to a purchase agreement between Nephros and Lambda Investors. It was important to focus on the ophthalmic area because of its frequency of surgeries and the aging population. Ardian’s flagship product. “But they reflect the maturing of mini sectors like orthopedics and cardiovascular stents and even hypertension drugs.194.ford@ahcmedia. omar. “They’re important so much because they’re large or bringing in current revenue. outside the U. 2010). “Without it they would be stuck in more mundane product lines that were cutting edge a couple of years ago. “This very large transaction enables Novartis to address . Lambda Investors purchased in a private placement 60. and cost efficiencies that can be reinvested in research and other growth opportunities. plus they have recovered from the recession and their balance sheets are very strong so they have cash and access to significant financings. and Canada.226 shares of its common stock and warrants to purchase an aggregate of 55. Copyright © 2011 AHC Media. California) (Medical Device Daily. .575 shares of its common stock.” Cohen said “It’s an important transformative move by [Boston Scientific]. It has received the CE mark and Australia’s Therapeutic Goods Administration listing. Massachusetts) $225 million purchase of Sadra (Campbell. but without [Sadra]. Medtronic reported snagging the firm for $800 million plus milestones for its investigational catheter-based treatment for uncontrolled hypertension.” The report also included Medtronic’s acquisition of Invatec (Roncadelle. “But by way of qualitative measures . 22. or ablation of the nerves lining the renal arteries. Sadra is developing a fully repositionable device for percutaneous aortic valve replacement to treat patients with severe aortic stenosis. 16. Dec. Italy) for $350 million and its purchase of Osteotech (Eatontown. New Jersey) for $123 million. MARCH 11.” He added that “the underlying dynamic is that there is Walden a dramatic worldwide aging population – so ophthalmic surgery and eye conditions are arguably the most prevalent surgery. They need to grow.651. along with Boston Sci’s acquisition of Sadra. They open up new minimally invasive treatments that were formerly conducted by open surgery or drugs.” But in no way is it a game changer. He said that companies will look for the best growth markets in a way that’s complimentary to their offerings. “Sadra is an acquisition that is Boston Scientific’s entry into what is arguably the next big growth area. Nov. One such deal was Boston Scientific’s (Natick. “I think there will [continue to] be large transactions. Cohen said that he continues to see the big deals in med-tech’s future. . Switzerland) for $51. but that’s by way of size. 2010).” Another important deal cited in the report was the Ardian (Mountain View. .” he said “The bar is now raised for companies to make acquisitions.medicaldevicedaily. large businesses with slow growth. Speaking on the deal.” Cohen told MDD. please call MEDICAL DEVICE DAILY™ Customer Service at (800) 888-3912.6 billion. Cohen told MDD. Switzerland) 77% stake in Alcon (Huenenberg.” Cohen added that this was going to prompt larger companies to acquire smaller companies to effectively grow. Visit our web site at www. 201 1 MEDICAL DEVICE DAILY™ PAGE 7 OF 10 Advisory Continued from Page 1 paternalism by the former FDAer. shape or form. As for what kinds of data should be required to establish the validity of a single-nucleotide polymorphism’s (or a group of SNPs) predictive power. citing “a couple of problems” with the GAO report. who took a swipe at Pendergast with the remark.” She also pointed out “when the GAO sent in the [samples of] spit to the companies. they sent it in twice” to the firms with two different sets of demographic data. several panelists said cohort studies might offer data that case control studies will not.” suggesting that absolute risk “be very prominently displayed” in gene testing reports.” Also addressing the panel during the open public hearing was Diana Zuckerman.” As has been widely reported.FRIDAY.” Upon further inquiry by Medical Device Daily. . of the University of North Carolina (Chapel Hill.” Zuckerman said FDA is not a particularly good source of patient information generally speaking. DTC tests present “a problem with economics. “FDA tried very hard to find a set of speakers that was balanced” and that he “would be surprised to hear that the speakers are antiDTC testing.”There’s nothing wrong with saying [a test] tells only part of the story. “FDA did not ask speakers about their position up front. but the panel was not fond of the idea that a given test should be available to only some demographic groups. The issue blew into public view last year after FDA commenced with enforcement.S. of Boston University (Boston) said “even cohort studies would be difficult. Visit our web site at www. Sr.” She also remarked. Panelist David Ranshoff. “the bottom line from actual studies is that when people attempt to learn something. a partner in the management consulting firm PRTM (Washington) told Medical Device Daily that See Advisory. “the concordance on the actual analytical validity was 100%. Regarding the notion of unfettered access to personal genomic information. but rather invited individuals we believed had the ability to share unique and relevant insights on the various aspects of the topic being considered by the panel. the panel largely concluded on the first of the two-day hearing that for the most part. outside the U. Pendergast also hinted at a profit motive behind physician attitudes. Pendergast said. “your labs will be paid for the testing” if DTC companies can’t do business. although panelist Ralph D’Agostino. who said she had spent 18 years at FDA..” She also took aim at the report filed by the Government Accountability Office (GAO) for last year’s hearing in the House. but argued that the idea that a positive outcome in a DTC test should compel a referral to a profession “is beyond the scope of government’s control over consumers. “I think this panel has not been well served by this hearing. She pointed out “there haven’t been major problems with HIV and pregnancy tests. the first 11 as a lawyer and the last seven as deputy FDA commissioner. Page 10 To subscribe. “I’ve seen patient booklets approved by FDA.” some of which “are 50 pages long . FDA spokeswoman Erica Jefferson said in an e-mail. Pendergast also noted “there were no enthusiasts [for DTC testing] invited to speak” on the first day. they are not upset at what they learn.” She said FDA “took away a number of useful insights that we’ll continue to review in the weeks ahead to determine the best path forward for regulating these complex testing devices. The latest FDA employee to take umbrage with the agency was Mary Pendergast. the panel indicated that risk information in gene testing reports should probably refer principally to absolute risk of acquiring a disease rather than relative risk. director of the Office of In Vitro Diagnostics at FDA. followed by a hearing in the House Energy and Commerce oversight and investigations subcommittee during which lawmakers on both sides of the aisle blasted sponsors of DTC gene tests. such tests should be available only with a prescription. call (404) 262-5547. North Carolina) said “relative risk has been almost outlawed by the medical journals” because of contextual issues. She added that while DTC opponents received 30 minutes to make their cases on the first day of the hearing. of the National Research Center for Women and Families (Washington). Pendergast said “the medical profession has objected every time the government has attempted to give direct genetic information” to consumers and patients. During the panel’s responses to the FDA questions.medicaldevicedaily. “I’m not a lawyer. said in response to Pendergast’s allegations about a stacked deck.” Alberto Gutierrez. Reproduction is strictly prohibited. But frankly. and not consumer friendly in any way. Taking on medical paternalism.” said Pendergast. . its medical paternalism” that drives physician resistance to DTC gene tests. please call MEDICAL DEVICE DAILY™ Customer Service at (800) 888-3912. saying that for doctors.” Jim Prutow.” Zuckerman said. Copyright © 2011 AHC Media. PhD.” “I believe that the standard for these tests should be higher than for tests interpreted by physicians. She said that despite GAO’s claims.” she continued. “you get money twice. while another panelist said “absolute risk is what patients tend to understand the best.” first for the prescription and then for a consultation. who started by asserting that the FDA presentations should have been held the first day of the hearing rather than the second. Left up in the air is the question of what kinds of evidence the agency will require to support a claim that a particular single-nucleotide polymorphism (SNP) – or a group of SNPs – is indicative of propensity toward a disease state. PhD. because “the risks are higher and the benefits are questionable.com. only 10 minutes were set aside for presentations by supporters on the second day. and Canada. MD.” adding that staff at the National Institutes of Health “are much better at providing patient information. PhD.” “If we stick to your recommendation that people go to you twice. MARCH 11. . and Canada. Siemens Global Product Manager for the Biograph mMR told Medical Device Daily the company signed a research agreement with Klinikum rechts der Isar to identify the most promising and relevant clinical applications. the shielded detector ring reduces the bore size for examination to 60 cm.medicaldevicedaily. according to Georgi. 2010) GE Healthcare (Chalfont. PET-MRI also shows promise for the evaluation of the cardiac system. 201 1 MEDICAL DEVICE DAILY™ PAGE 8 OF 10 ECR Continued from Page 1 that ended here earlier this week. There is no question of bringing the delicate vacuum photomultiplier tubes used in PET anywhere near that magnet. Reproduction is strictly prohibited. but challenged by some patient populations. MD. Copyright © 2011 AHC Media. A Biograph mMR was installed in early March 2011 at the University of Tübingen which also agreed to a Siemens research agreement. and close enough in time to allow a reliable anatomical registration for an overlay of the two images. nine inches. Siemens solved technical issues for scaling up the APD detection surface to 26 cm. Engineers also succeeded in stacking offset layers of crystal detectors capable of collecting more photons from the PET isotope.com. director of the clinic for nuclear medicine at the Technical University of Munich Hospital said the promise of MRI is “to diagnose diseases at a very early stage. Last year at ECR. “Many neurological conditions are suitable for evaluation with PET/MR. epilepsy. The Biograph system can handle up to 76 individual coil elements receiving from those elements up to 32 RF channels. a patient is positioned in the head coil and aligned on top of the embedded spine coil while four mMR RF coil pads are placed the length of the patient’s body. Allen Li. The magnetic force of the MRI steady field magnet is already powerful enough to makes syringes and scalpels fly through the air. Reinventing PET detectors The current generation of PET detectors are tubes that pick up the signal of the radioisotopes coursing through the bloodstream. incumbent method for diagnostics. MD.” he said.” “We plan to use the system for cancer follow-up and for reducing radiation exposure to patients. Massachusetts General Hospital (Boston) has ordered the scanner and Georgi told MDD two further installations are expected in the U. and brain tumors. from the university’s department of nuclear medicine was been responsible for the system delivered in November 2010.S. Placed inside the 70 cm ring of the Verio MRI. nor the more disruptive electromagnetic field created by the gradient pulses of the radiofrequency (RF) coils used in MRI scanning. PET-MRI also creates opportunities the development of new biomarkers or new therapeutic approaches. The challenge ahead for Siemens is now demonstrating the clinical value for this high-tech accomplishment. they are shielded from the gradient field. CT is so much faster than MRI. Alexander Drzezga. for the first time placing a ring of avalanche photodiode (APD) PET detectors inside the bore ring of a 3 tesla Verio MRI for simultaneous acquisition of images from both modalities. a standard size for whole body imaging. call (404) 262-5547. dementia. enabling faster exam times with the largest PET coverage area available. He believes combining PET with MRI offers numerous clinical advantages. . For an examination. outside the U. Shown the new Biograph mMR. allowing coverage of 205 cm or six feet. offered the positive note that “about 90% of our patients would fit into the Biograph. he said.FRIDAY. Similar contracts are being set with clinics in Essen and Leipzig where the Biograph mMR will be installed this year.” Critical for MRI acquisition are the RF coils.S. from the Medical College of Wisconsin (Milwaukee). including neurodegenerative disorders. MD. Absence of radiation is a big plus CT exams today account for a third of all medical radiation. the PET scan and the MRI exam can be conducted sequentially. Yet. the Netherlands) introduced a silicon-based photomultiplier technology for a separately shielded PET detector unit that is safe enough to place next to the MRI. Mar 10. ■ To subscribe. as well as inflammation and vascular conditions. By placing the patient on a table that turns between the two machines. While FDA approval is pending for the Biograph mMR. UK) is pursuing this approach as well. and his studies include a head-to-head comparison with PET/CT. Jens-Christoph Georgi. The first Biograph mMR was installed at the prestigious Klinikum rechts der Isar at the Technical University in (Munich. and a competitive advantage Siemens engineered into the Biograph mMR are an array of parallel imaging coils enabling a whole body scan without repositioning the patient. though the Klinikum group in Munich reports an average of 20 minutes. While the APD detectors are insensitive to the steady field of the magnet. Philips Healthcare (Eindhoven. though they only represent about 8% of exams made by all modalities. Siemens engineers went further. to see the progression of disease and to use that information to develop a therapy plan precisely focused on the respective patient. Visit our web site at www. Markus Schwaiger. MARCH 11. and so well-established in clinical literature that it will be difficult to dislodge it as the preferred. (MDD. please call MEDICAL DEVICE DAILY™ Customer Service at (800) 888-3912. he said. Scan times are estimated at 30 minutes for whole body.” he said. Germany). even as the device tax repeal bill continues to gather sponsors.medicaldevicedaily. 201 1 MEDICAL DEVICE DAILY™ PAGE 9 OF 10 Continued from Page 1 Competitiveness Act of 2011.com To subscribe. which would have at least some jurisdiction over such legislation.S. and Canada. implicitly. The difficulty for fans of patent reform. processes and products. “We are encouraged that the action plans implemented by our teams have resolved the observations identified by the FDA in both warning letters. adding that while the U. The bill had attracted 103 sponsors at the beginning of the week. The Senate Finance Committee. please call MEDICAL DEVICE DAILY™ Customer Service at (800) 888-3912. Authored in part by Rep. outside the U.” Paulsen’s device tax bill gains five sponsors Bill would make R&D tax credit permanent Another item of interest arising from inside the Beltway is a bill that would permanently fix the research and development tax credit into U. reform in general.” Ubl said. whatever their views of the various issues connected with the idea.govtrack. from the Democratic Party. Baucus could demand offsets. Steve Ubl. Given the budget-balancing sentiment prevailing in Washington this year. In a statement e-mailed to Medical Device Daily.” a failure of which would “put in jeopardy the future of our nation’s economy. leadership in medical technology.” a comment probably intended to address provisions for damage awards. said American device makers commend the authors of the bill. who is a member of the House Energy and Commerce Committee. Copyright © 2011 AHC Media. getting a companion bill through the Senate will require substantial help from Senate Democrats.” He said U. The House passed a patent bill in 2007.FRIDAY. call (404) 262-5547. Mark Leahey. tax law. however. Minnesota facility and another from June 2009 regarding the company’s manufacturing facility in Juncos.” Leahey concluded that a modern patent system is “absolutely critical for medical device innovators to have an adequate assurance that their intellectual property will be protected and we look forward to working with both parties and chambers of Congress to achieve this goal. and around the globe with innovative life-saving and life-enhancing technologies. which still has only three members who have signed on to support the bill. MDMA remains concerned that establishing a new post-grant review process will overburden PTO and provide a potential vehicle for abuse by some parties. ■ Mark McCarty. Washington) said the association “appreciates the Senate’s efforts to improve the patent bill from earlier versions. . Erik Paulsen continues to draw sponsors for his bill aimed at repealing the device tax imposed as part of the Patient Protection and Affordable Care Act of 2010. president/CEO of the Medical Device Manufacturers Association (MDMA.” said William Hawkins.S. is chaired by the author of one of the healthcare reform bills last year and the bill that originally included the device tax. no bill had passed until earlier this week.com. Since then. Visit our web site at [email protected]. “We will continue to provide the highest quality products and we are actively working to ensure the changes we have made are appropriately incorporated across all of our global facilities.S. its continued leadership is by no means assured. is that passage of a bill in one chamber of Congress guarantees nothing about what will happen in the other. MARCH 11. Reproduction is strictly prohibited. H. The bill has not garnered any additional support. who number in the majority. a move heralded by one of the other major device industry associations. We have developed a culture of prevention and accountability across our entire enterprise and we will continue to invest aggressively in the continuous improvement of our people. 703-268-5690 mark. author of the best-supported device tax repeal bill currently in play in Washington. the Advanced Medical Technology Association (AdvaMed.R. president/CEO of AdvaMed. such as the end of fee diversion for the United States Patent and Trademark Office.S.” Washington development for industries like medical technology to level the playing field with foreign governments eager to attract American jobs and develop home-grown competitors to American firms. Erik Paulsen (R-Minnesota).” The principal sponsor of the bill is Rep. Medtronic resolves FDA warning letters Medtronic (Minneapolis) said the FDA has informed the company that issues noted in two warning letters – one from November 2009 regarding the company’s Mounds View.” “We believe the bill introduced today would contribute to continued U. as well as our industry’s ability to provide patients here in the U. chairman/CEO of Medtronic. While the House GOP needs no help from Democrats to pass the bill. In a March 9 statement. only to watch the Senate focus its efforts on other priorities. 942 states specifically that it is drafted “to amend the Internal Revenue Code of 1986 to extend the research credit through 2012 and to increase and make permanent the alternative simplified research credit. Washington). Leahey went on: “While there are positive developments in this legislation. although the Obama administration has thrown its weight behind the Senate bill and. Max Baucus (D-Montana). “is currently the recognized world leader in medical technology. but has pulled in another five sponsors according to the website www. tax policy must “sufficiently support research and Rep. Kevin Brady (R-Texas).S. which would be hard to come by in the current fiscal environment.S. Puerto Rico – have been resolved. He said that the larger firms will have the genomic capability to fully exploit any form of DTC marketing to the fullest and have an interest in molecular diagnostics. PinPointe makes laser-based devices for the treatment of infections. Bauchner is currently the editor-inchief of the Archives of Disease in Childhood. Louis) said the FDA has approved the use of molybdenum-99 (Mo-99) derived from lowenriched uranium (LEU) in the production of technetium99m (Tc-99m) generators. cardiologists. the impact on companies in this space will be substantial.medicaldevicedaily. will become the next JAMA Editor-in-Chief on July 1. California) said Aetna. Bradley was marketing manager at SenoRx. MARCH 11. is an assistant professor of surgery. at Harvard Medical School and is also the director of research for the California School of Podiatric Medicine at Samuel Merritt University. supplied to hospitals and nuclear pharmacies by Covidien’s Mallinckrodt business. Advisory Product Briefs • Covidien (St. .S.” partly because these smaller firms don’t have the quality control/regulatory affairs staff and “have a difficult time creating the processes and the culture that’s required. • Teleflex (Limerick. he said. DPM.com received market clearance from the FDA. “so we’re going to see more and more companies look at how they’re going to grow in the molecular [diagnostic] space. Visit our web site at www. “What I believe is going to happen is a number [of firms currently in the business] will be acquired by more established IVD firms. “I think it’s going to be challenging to continue to get funding” for firms that are VC-backed. • Howard Bauchner. Side holes on the tip of the catheter are designed to pull blood from all sides of the catheter. Adam Landsman. Tc-99m is produced when Mo-99 decays following uranium irradiation. Pennsylvania) said its Arrow NextStep Antegrade Chronic Hemodialysis Catheter has To subscribe. formerly of Abbott Laboratories to its board. call (404) 262-5547. Compared to traditional chronic hemodialysis catheters. MD. AlloMap Molecular Expression Testing is a noninvasive gene expression test used to aid in the identification of heart transplant recipients with stable allograft function who have a low probability of moderate/severe acute cellular rejection at the time of testing in conjunction with a standard clinical assessment. a provider of healthcare insurance. • PinPointe (Chico. Mark Willig as executive VP of North American sales. the company said. Willig previously was GM and chief commercial officer at Exiqon.mccarty@ahcmedia. firms “are going to be significantly impacted” by further regulatory requirements. AlloMap testing measures the expression levels of 20 genes from a blood sample. Macdonald has been with Agendia for the past eight months in a consulting role. Agendia makes genomic tests for tumor gene expression profiling. and Canada. according to the American Medical Association (Chicago). Tc99m is a critical medical isotope used in diagnostic and functional studies of organs and anatomical systems. the official publication of the Royal College of Paediatrics and Child Health in the UK. Nordion is a specialty health science company that provides products used for the prevention. nephrologists and oncologists) to better diagnose and treat patients.” Prutow said.” which he said is the fastest growing space in the IVD field. he said. California) said that Adam Landsman will head up the company’s medical advisory panel. The venous port releases blood into the superior vena cava. • XDx (Brisbane. The arterial port draws blood from the right atrium. Murphy was VP of licensing and business development for Abbott Laboratories for 10 years. prior to his retirement in 2010. 703-268-5690 mark. The information from these studies is used by many medical specialists (including radiologists. has determined that AlloMap is “medically necessary” for monitoring rejection in heart transplant recipients more than one year after a heart transplant. The ports are significantly separated to enhance flow and minimize recirculation. Prutow pointed out that investors are very likely to rethink their commitments to at least some of the smaller firms in the field. and Doug Bradley as VP of global marketing. when they take the recommendations. The catheter is designed to attain long-term vascular access for hemodialysis and apheresis.FRIDAY. but use a risk-based methodology” to make the call. 201 1 MEDICAL DEVICE DAILY™ PAGE 10 OF 10 People in the News • Agendia (Irvine. please call MEDICAL DEVICE DAILY™ Customer Service at (800) 888-3912. Bauchner is a professor of pediatrics and community health sciences at Boston University Schools of Medicine and Public Health. Continued from Page 7 in the current environment. doesn’t require prescriptions for everything. used in more than 80% of all nuclear medicine studies.com. diagnosis and treatment of disease. Copyright © 2011 AHC Media. outside the U. It is indicated for use in adult patients. Woodruff is the VP and special advisor of BC Hydro. California) has named David Macdonald as the company’s chief operating officer. “I hope FDA. The catheter includes a step-tip catheter’s ease of insertion and a split-tip catheter’s sustained high flow. Still. • Nordion (Ottawa) has named Janet Woodruff of BC Hydro and Sean Murphy. The combined expression of these genes is represented as an AlloMap test score. Tc-99m is a medical isotope. ■ Mark McCarty. Reproduction is strictly prohibited. the ports are reversed to match the heart’s natural blood flow dynamics. or CTCs. of the UCLA Department of Pathology and Laboratory Medicine. Kimberle Chapin. Metastasis is the most common cause of cancer-related death in patients with solid tumors and occurs when these marauding tumor cells leave the primary tumor site and travel through the blood stream to set up colonies in other parts of the body. Reproduction is strictly prohibited. Circulating tumor cells. outlined in a 2009 paper in Angewandte Chemie. This second-generation CTC-capture technology was shown to be capable of highly efficient enrichment of rare CTCs captured in blood samples collected from prostate cancer patients. and its symptoms can be associated with many different conditions. and researchers have long endeavored to track and capture them. A study from the microbiology lab at Rhode Island Hospital (Providence. Its true prevalence and clinical impact is unknown because current methods of detection exhibit poor sensitivity when compared to molecular amplification methods. TV is not currently a reportable disease in the United States. The researchers also noted a high prevalence of TV in women in the 36. “Despite a worldwide prevalence rate likely to be double that of gonorrhea or chlamydia combined. and it captures a greater number of CTCs. please call MEDICAL DEVICE DAILY™ Customer Service at (800) 688-2421. . grabs CTC’s . which play a crucial role in cancer metastasis. and Canada. which is commonly used in OB/GYN patients. The new CTC enrichment technology is based on the research team’s earlier development of ‘fly-paper’ technology.S. . .to 45. In the Rhode Island population with a low prevalence of sexually transmitted infections. a University of California.com. New test is more accurate in detecting STI disease . The current gold standard for determining the disease status of tumors involves the invasive biopsy of tumor samples.” Velcro-like nanoscale technology identifies. they found that the AFFIRM assay.MDD’s Diagnostic Extra ADDITIONAL DEVELOPMENTS FRIDAY. . The prostate cancer patients were recruited with the help of a clinical team led by physicians Matthew Rettig.5-by-5–centimeter microfluidic chip.year-old age group – a group not normally included in the recommended STI screening criteria. “We also found that TV was most prevalent in women ages 36 to 45 and in women ages 51 to 60. The new approach could be even faster and cheaper than existing methods. have been known to science for more than 100 years. says.S. .” The authors tested the effectiveness of the only FDA cleared diagnostic test for differentiating and identifying the pathogens associated with bacterial vaginitis compared with another test that uses a special type of amplification for the detection of TV. While this was definitely surprising and a new finding in these age groups. of the UCLA Department of Urology. and Jiaoti Huang. we found that Trichomonas vaginalis infection was higher than that of chlamydia and gonorrhea. In a study published this month and featured on the cover of the journal Angewandte Chemie. MD. but in the early stages of metastasis. the UCLA researchers report the successful demonstration of this “nano-Velcro” technology. . allowing for early detection and diagnosis. Through their study. Trichamonos vaginalis (TV). The lead author of the study. it is often difficult to identify a biopsy site. known as the APTIMA assay. which they engineered into a 2. Copyright © 2011 AHC Media. Rhode Island) has found that a new test may be more accurate in identifying a common sexually transmitted infection (STI). doctors can essentially perform a “liquid” biopsy. produced both false positive and false negative results. including Rhode Island Hospital. director of the microbiology lab at Rhode Island Hospital. the researchers said. The technology involves a nanopillar-covered silicon chip whose “stickiness” resulted from the interaction between the nanopillars and nanostructures on CTCs known as microvilli. supporting the need for routine testing for TV and suggesting a different reason for why women may be seeing their physicians with certain gynecologic complaints. outside the U. creating an effect much like the top and bottom of To subscribe. in the blood. Los Angeles (UCLA) research team has developed an innovative device based on Velcro-like nanoscale technology to efficiently identify and “grab” these circulating tumor cells. By capturing CTCs in blood samples. The authors studied the specimens from 766 women. Visit our web site at www. MARCH 11. Clinical trials of the assay were recently completed and it has been submitted to the FDA for clearance. Chapin says.medicaldevicedaily. TV is a STI that can affect both men and women. . 201 1 IN ONE OF MED-TECH’S KEY SECTORS PAGE 1 OF 2 Keeping you up to date on recent developments in diagnostics . The study is now published online in advance of print in the Journal of Clinical Microbiology. while the APTIMA assay detected 36% more TV-infected women yielding a sensitivity of 100% and no false positives. call (404) 262-5476. this data has now also been substantiated in the FDA clinical trial data involving multiple sites in the U. as well as improved monitoring of cancer progression and treatment responses. Now. Patsalis calls the results “very exciting” but said the test needs to be trialed in a larger study of about 1.. further enhancing the device’s efficiency. yet detection of changing flow patterns in real-time remains a challenge. Reuters reports. In athero-prone regions.medicaldevicedaily. from which convective heat transfer was measured as a function of the voltage signals. published in a recent issue of Nature Medicine. In addition to the Velcro-like effect from the nanopillars. MARCH 11. Hsiai’s group developed a micro-electro-mechanical system (MEMS) by depositing titanium and platinum on a flexible polymer membrane and patterning them to form the sensing elements. . Simple blood test can detect likelihood of Down Syndrome . In the regions of atherosclerotic lesions.” Philippos Patsalis. Researchers say that a simple blood test can predict whether a baby is likely to have Down Syndrome. please call MEDICAL DEVICE DAILY™ Customer Service at (800) 688-2421. . and Canada. . albeit inflammatory and otherwise considered normal arterial regions. In the initial. The risk increases as women get older. small trial of 40 pregnant women. known as shear stress. Thermosensor can detect early signs of atherosclerosis . outside the U. the mixing produced by the microfluidic channel’s architecture causes the CTCs to have greater contact with the nanopillar-covered floor. The risk of having a baby with Down Syndrome occurs when a child has three copies of chromosome 21 instead of the normal two. call (404) 262-5476. The risk for a 40-year-old mother is 16 times that for one who is 25. Tzung Hsiai. “The innovation of this study lies in the convective heat transfer strategy to detect changes in output voltage signals in the non-obstructive. more invasive procedures. “We believe we can modify this test and make it much easier and simple.S. second-generation device adds an overlaid microfluidic channel to create a fluid flow path that increases mixing. Although diet and lifestyle changes can often reverse atherosclerosis in its earliest stages. The sensor measured a high voltage upstream from the part of the blood vessel that harbored the atherosclerotic plaque. Patsalis’ method examines differences in the DNA methylation patterns. changes in voltage signals. The scientists concluded that the MEMS thermal sensor method could sensitively detect pre-atherosclerotic regions that otherwise showed no clinical signs of atherosclerosis. This causes changes in convective heat transfer from the sensing element to the flow field. medical director of the Cyprus Institute of Neurology and Genetics explained.com To subscribe. Down Syndrome occurs in 1 in 700 live births and is the most common genetic cause of mental retardation. 201 1 MDD’S DIAGNOSTIC EXTRA PAGE 2 OF 2 Velcro. They deployed the sensor via an angiogram catheter into the aortic and abdominal arteries of rabbits that had eaten a high fat. Copyright © 2011 AHC Media. and scientists have been looking for new less invasive ways to test for Down Syndrome and other genetic issues. . and thus.ford@ahcmedia. high cholesterol diet. An electric current passed through the sensing element and generated a thermal layer in the flow field. is intimately involved in oxidative stress and inflammatory responses that lead to atherosclerosis. and 26 normal fetuses. Visit our web site at www. an Associate Professor of Biomedical Engineering and Cardiology at the University of Southern California (Los Angeles) said. DNA differences between the mother and the fetus can be shown to accurately predict which fetuses are at risk of developing the syndrome. MDD Staff Writer omar. The study’s lead author. researchers were able to correctly diagnose 14 cases of extra copies of the chromosome. highlighting its clinical potential. and a control group that had eaten a normal diet. – Compiled by Omar Ford. which control levels of genes between mother and fetus.FRIDAY. blood flow is disturbed. This test is generally done at about 15 or 16 weeks gestation and involves taking amniotic fluid from the mother by inserting a hollow needle into the uterus. and a low voltage downstream. “Such a non-invasive approach will avoid the risk of miscarriages of normal pregnancies caused by current. (and then) we can have something ready to be introduced into the clinic.” Scientists have demonstrated that frictional force acting on the walls of vessels by blood flow. the flow is disturbed.000 pregnancies and could lead to changes in clinical practice within the next few years. The new.” researchers conclude in their findings. The MEMS thermal sensor used convective heat transfer to detect pre-atherosclerotic regions of arteries that otherwise showed no clinical signs of atherosclerosis.com. . no real-time means of detecting pre-atherosclerotic regions exists. Amniocentesis is the current test that is performed to find if a baby is likely to be born with Down Syndrome. The test involves taking a small amount of blood from the mother when she is between the 11th and 13th week of her pregnancy to detect extra copies of chromosome 21 in the fetus. This test also carries a small risk of spontaneous miscarriage. The MEMS sensor method has the advantage of being both minimally invasive and sensitive. The technology has the potential for widespread and rapid application during diagnostic angiograms. Reproduction is strictly prohibited.. generally 1 to 2%. A new study published in the Annals of Biomedical Engineering shows that a Micro-Electro-Mechanical System (MEMS) thermal sensor deployed by an angiogram catheter can detect the earliest stages of atherosclerosis.