The Institute for Health Technology Studies (InHealth) has awarded a grant of $240,000 to an international consortium of researchers, for a study that will assess the effects of hip replacement therapy on the employment and retirement decisions of older adults. Led by researchers at the Universita Bocconi (Milan), the consortium also includes investigators at the University of York (York, UK), and the Johns Hopkins University School of Public Health (Baltimore).

Hip replacement has been shown to improve quality of life by restoring physical mobility and reducing pain. However, there is evidence that a substantial number of patients who might benefit from the procedure do not receive it. Currently, between 200,000 and 300,000 hip replacement procedures are performed in the United States each year. But in the 2002 U.S. Health and Retirement Study, nearly 50% of retired respondents ages 55 to 64 reported arthritis and other musculoskeletal conditions as the most significant reasons they could no longer work.

Early retirement triggered by such conditions is a contributing factor to the current financial crises of Europe’s pension systems and of the U.S. Social Security trust fund, which is projected to be exhausted by 2037. Under their grant from InHealth, the consortium’s researchers aim to generate evidence on whether hip replacement can enable people with debilitating musculoskeletal conditions – including severe pain, osteoarthritis, and rheumatoid arthritis – to continue working, consequently easing the financial pressure on these critical retirement systems.

“Industrialized nations around the world are trying to accommodate the mounting cost pressure that their aging populations place on limited public and healthcare resources,” says Martyn Howgill, InHealth’s executive director. “InHealth’s grant will help assess the impact of reduced disabilities made possible by hip replacements on public and private retirement funds.”

Howgill adds that this is the first time InHealth has awarded a grant to academic institutions outside the United States.

For the study, researchers will examine economic and sociodemographic factors that contribute to an individual’s decision about receiving a hip replacement. Data sources for the study will include the English Longitudinal Study of Aging; the Survey of Health, Aging, and Retirement in Europe; and the U.S. Health and Retirement Study. The three sources collect similar financial and other patient information, including current and prospective pension payments; employment; health conditions; physical health; healthcare interventions; and sociodemographic characteristics of individuals 50 years of age or older and their partners.

Investigators will then compare patients who received a hip replacement with those who did not, to determine how the treatment affected their employment and retirement decisions. Based on this comparative data, they will estimate the impact of hip replacement on national pension and Social Security systems, and the potential outcome of financial incentives – such as tax breaks – that could encourage working adults to delay retirement.

“We chose to study hip replacement in continental Europe, England, and the United States because of the country variations in incentives for retirement and the number of older adults still in the work force,” says Ruben Mujica-Mota, PhD, a senior research fellow at the Center for Research in Healthcare Management at the Università Bocconi and lead investigator for the study. “We aim to contribute evidence to the growing debate in these countries over policy measures to reduce the gap between available tax revenues and the public expenditures required to provide Social Security and pension benefits.”

The consortium conducting the study, “The Effect of Medical Devices on Health and Retirement: The Case of Hip Replacement Therapy,” was drawn together by the European Health Technology Institute for Socio-Economic Research (Brussels), an independent research institute aimed at developing data and evidence on the social and economic value of medical technology and its impact on the economy and welfare of European countries.

Source:
Caitlin Hool
InHealth: The Institute for Health Technology Studies

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, announced the Canadian launch of its Trifecta™ aortic stented tissue valve. The first procedures in Canada were performed by Dr. Anson Cheung, Surgical Director of Cardiac Transplantation for Providence Health Care.

The Trifecta valve is a clinically proven replacement valve for patients with diseased, damaged or malfunctioning aortic heart valves. The next-generation tissue valve has a tri-leaflet stented pericardial design, which offers excellent hemodynamic performance.

Commenting on his experience with the Trifecta valve, Dr. Anson Cheung said, “I am very excited to see the introduction of the St. Jude Medical Trifecta valve in Canada. I have been implanting this valve as part of the IDE (investigational device exemption) trial and am very happy with its ease of implant and handling. Also, the hemodynamic performance is superb.”

The Trifecta valve is constructed using a polyester and tissue-covered titanium stent, or base, to ensure structural integrity of the valve. Designed to be implanted in the supra-annular aortic position, the valve features leaflets manufactured from pericardial tissue attached to the exterior of the valve stent. This design allows the leaflets to open more fully and efficiently, mimicking the performance of a healthy aortic heart valve, while also mitigating tissue abrasion through tissue-to-tissue (stent-to-leaflet) contact. Additional attributes of the Trifecta valve include proprietary tissue fixation and the St. Jude Medical patented Linx™ AC Technology, an anti-calcification treatment designed to reduce tissue mineralization (hardening), a common complication in previous generations of tissue valves.

“St. Jude Medical has developed a next-generation aortic stented tissue valve that is specifically designed for improved hemodynamic performance, durability and implantability,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular Division. “The Trifecta valve has demonstrated outstanding hemodynamic performance, improving the quality of life for patients with diseased aortic heart valves. We look forward to continuing to grow our legacy of market-leading valves with this advanced technology and will continue to put more control in the hands of physicians who treat cardiac patients worldwide.”

The Trifecta valve offers several features that improve the ease of implantation, including the valve’s unique holder, designed to improve visibility and cuff access for suturing, and the valve’s simplified sizing process, offering physicians more control in choosing the appropriate replacement valve for each patient’s heart.

For more than 30 years, St. Jude Medical has demonstrated a commitment to cardiac surgery, offering patients the gold standard in mechanical heart valve performance and tissue valve durability. The Trifecta stented tissue valve further expands the St. Jude Medical valve product portfolio, which includes market-leading mechanical heart valves, valve annuloplasty rings and porcine tissue valves with superior durability for both the aortic and mitral valve.

Source:
St. Jude Medical
Providence Health Care

Tomophase Corporation, developer of the non-invasive Optical Coherence Tomography Imaging System (OCTIS™) and other devices, announced that it has received FDA 510(k) clearance to market OCTIS.

Tomophase is a leader in the development of OCT brochoscopically-based imaging systems for interventional pulmonology. OCTIS is comprised of a single-use disposable optical catheter and imaging console. Initially OCTIS will be deployed for tissue imaging of airways and lungs, followed by diagnostic and therapeutic applications.

The National Lung Screening Trial (NLST) recently released by the NCI represents an example of how OCT will be applied. In the NLST, the risk of dying from lung cancer was reduced by 20% when the subjects, (>50,000) former smokers, were given low-dose CT scans which resulted in identifying lethal tumors at an earlier, more treatable stage. Tomophase OCTIS has the potential to monitor these patients by imaging pulmonary tissue following a CT scan using laser light rather than radiation.

“We are delighted to receive the 510(k) for our new, novel OCT Imaging System. This clearance reflects the hard work and dedication of our employees and consultants over the past five years. At the present time, there is a lot of excitement in interventional pulmonology due to the emergence of several new innovative, medical technologies and potential applications. Our company is committed to providing new medical imaging products to improve the diagnosis and treatment of diseases of the lung and airways including asthma, emphysema and lung cancer,” said Ralph Johnston, President and COO.

Dr. Peter Norris, Chairman and CEO added: “Our first 510(k) represents a giant step forward in our development of OCT technology for interventional pulmonology, heretofore a greatly underserved market. We plan to consistently expand our system’s capabilities in order to maximize the potential for safe, cost-effective, optical imaging, diagnostics and therapy for the management of pulmonary disease.”

Source: Tomophase Corporation

The Scientist unveils the best life science innovations of the year

The Scientist, Faculty of 1000′s magazine of the life sciences, has announced the winners of the “Top 10 Innovations of 2010.” The Scientist invited a panel of expert judges to evaluate life science technologies and determine the ten most exciting tools to hit the life sciences this year.

Molecular chemist Neil Kelleher of Northwestern University, sequencing pioneer Jonathan Rothberg, Princeton University genomicist Amy Caudy, and Pacific Northwest National Laboratory biologist H. Steven Wiley reviewed more than 60 entries in the third annual Top 10 Innovations competition to narrow down the products to the 10 best.

This year’s winners include essential tools, such as sequencers, imagers, and cell counters, that have the potential to simplify and streamline work in biology labs; and cutting-edge advances, from tailor-made disease-model cell lines to heart cells derived from induced pluripotent stem cells.

The Gold honor was awarded to Pacific Biosciences, for its breakthrough product PacBio RS, which enables single molecule, real-time, or SMRT, detection of biological processes, for the first time. The Silver went to Sigma-Aldrich and its CompoZr custom zinc-finger nuclease service. This new portfolio of products offers genetically modified mammalian cell lines for a broad spectrum of applications. EMD Millipore’s Scepter Handheld Automated Cell Counter claimed bronze as the only handheld, automated cell counter available today.

The Maestro Dynamic, developed by Cambridge Research & Instrumentation is a kinetic all-optical in-vivo fluorescence imaging system that generates real-time images of temporal biodistribution and biological activity. Reinnervate Limited presented Alvetex®, a unique and highly porous polystyrene scaffold that enables the routine, reproducible and cost-effective creation of 3D cell cultures in the laboratory.

The Attune Acoustic Focusing Cytometer from Applied Biosystems also made the Top 10. This product enables scientists to gather statistical data on a large number of heterogeneous cells to study parameters within a cell population, including size, complexity, phenotype and health.

“The 2010 winners represent exceptional combinations of invention, vision and utility and we look forward to seeing how these products will impact the life sciences”, said Mary Beth Aberlin, Deputy Editor.

The Top 10 Innovations of 2010:

1. PacBio RS; Pacific Biosciences
2. Genetically engineered disease model cell lines; Sigma-Aldrich
3. Scepter Handheld Automated Cell Counter; EMD Millipore
4. Diffinity RapidTip™; Diffinity Genomics
5. iCell Cardiomyocytes; Cellular Dynamics International
6. Maestro Dynamic; Cambridge Research & Instrumentation
7. Alvetex®; Reinnervate Limited
8. Attune Acoustic Focusing Cytometer; Applied Biosystems
9. Gel Doc EZ Imager; Bio-Rad Laboratories
10. Preddator microplate dispenser; Redd&Whyte

Read the complete feature in The Scientist’s December 2010 issue. The article is available online here.

Source:
Eleanor Howell
Faculty of 1000: Biology and Medicine

The Boston Globe: “Massachusetts health officials published online yesterday the most comprehensive state database in the country listing payments drug companies and medical device makers have made to doctors, nurses, pharmacists, hospitals, and other health care providers. The report lists $35.7 million in payments from hundreds of companies for the six months between July 1 and Dec. 31, 2009 … About half of that money, or $16.4 million, went to physicians. This is the first time Massachusetts has made such information public. Under a law passed two years ago, any drug or device company doing business in the state is now required to report certain payments of $50 or more” and bans companies from giving gifts to doctors. “The Massachusetts database shows that 5,048 physicians, or about 12 percent of the state’s doctors, received payments” (Lazar and Kowalczyk, 11/23).

The Associated Press/MSNBC.com: The report also “said the payments included speaking and consulting fees, meals, and education and marketing programs. … Supporters say the law is designed to prevent companies from encouraging doctors to prescribe more expensive brand-name drugs rather than generics. Critics say the law is stifling research” (11/22).

Boston Herald: The published figures “immediately sparked concerns about the effect on spiraling health-care costs and doctors’ integrity. ‘There’s the potential for bias, and the potential for the increased cost of care,’ said Tufts Medical School professor Dr. Jerome Kassirer, ‘but the biggest concern is that the public just won’t trust their doctors anymore.’ … Many scientists defend the expenditures … ‘Education of health-care providers on these ever-changing treatments ensures that patients will receive the care they need and deserve,’ said Robert Coughlin, president and chief executive officer of the Massachusetts Biotechnology Council. ‘There is nothing nefarious about an expert health-care provider working to make this a reality’” (Crimaldi and McConville, 11/23).

© Henry J. Kaiser Family Foundation. All rights reserved.

A device called the GammaPod System, invented by the University of Maryland Entrepreneur of the Year, Cedric Yu, DSc, could eliminate the traditional surgery and radiation treatment ordeal of women with a early-state breast cancer, the inventor said at his award ceremony Nov. 11 at the University of Maryland BioPark.

With the GammaPod System, “We could save the whole breast so you don’t need surgery,” said Yu, who is the Carl M. Mansfield, MD, Endowed Professorship in Radiation Oncology with the University of Maryland School of Medicine.

Yu’s work and leadership have contributed to the international recognition of the School’s Department of Radiation Oncology. His pioneering developments in radiation treatment technology have improved the quality and efficiency of cancer treatments using radiation throughout the world.

In 2006, Yu patented a dedicated breast radiation therapy method, now called the GammaPod System, which was developed with the help of $3.5 million in Small Business Innovation Research grants from the National Institutes of Health (NIH).

With support from the University’s Office of Research and Development (ORD), he founded Xcision Medical Systems, LLC, to pursue the development of the high-precision, noninvasive system of treating early-stage breast cancer. Xcision, which is based in Maryland, plans is seeking GammaPod approval from the Food and Drug Administration.

“I was surprised and happy to be named Entrepreneur of the Year, not just for myself but happy that the University encourages entrepreneurship and recognizes the importance of theoretical research that converts into new knowledge and new products,” Yu said.

The GammaPod therapy will require only two or three concentrated radiation treatments of beams from thousands of directions precisely targeted to a tumor inside a breast, said Yu. It is a radical departure from conventional breast cancer treatment.

He said the good news today about treating breast cancer is that most cases are diagnosed early and that surgery and a long process of radiation treatments can be successful therapy. However, some cancer cells are often left outside of the tumor site and the highest radiation sometimes doesn’t reach the tumor.

“I started to think about the GammaPod concept in 1996,” he said. Yu took his concept to William Regine, MD, chair of the School’s Department of Radiation Oncology, who had envisioned a similar strategy for treating cancers of the body.

Regine said at the ceremony, “When Cedric showed me his concept, it was clear he had come up with a Stereotactic Body Radiation Therapy (SBRT) specific for early-stage breast cancer that had the potential to be paradigm changing. It’s a solution that could eventually lead to the use of SBRT alone, that is, no surgery thus, leaving women with no need of a scar to remind them of their breast cancer.”

Yu explained, “We can deliver a high enough dose to [neutralize] the tumor. Only two or three radiation treatments will be needed. The traditional 3-month ordeal can be shortened to three treatments only. You don’t need surgery. You don’t need standard radiation. No needle, knife, pain, anesthesia, and no scar.”

Yu cautioned that “to change the practice [of treating breast cancer] is not easy. It will take money, time, support of the university, hard work, but we will do it right. I hope by the end of next year we will have it approved.” He added, “The idea is really different and these [GammaPods] will be designed differently for different sites.”

University of Maryland President Jay A. Perman, MD, said, “Cedric Yu embodies what our mission ‘real world thinking and worldwide reach’ is really about. He makes that expression work.”

“Dr. Yu’s had a remarkable journey,” E. Albert Reece, MD, PhD, MBA, dean of the School of Medicine, told a standing-room-only audience at the BioPark. “In his teenage years in his native China, he spent 4 ½ years at a farm during Chairman Mao Tse-tung’s cultural revolution. While on that farm in his spare time, he studied anatomy and physiology and read The Barefoot Doctor. In his spare time!”

Yu earned an electrical engineering degree in China in 1982 and then moved to the U.S. where he obtained an MS degree in electrical engineering and a PhD in medical physics, both from Washington University in St. Louis.

With the help of the University’s ORD and NIH, Yu’s dream is becoming a reality. The first prototype system was installed at University of Maryland Medical Center in May 2010.

Says James Hughes, MBA, the University’s vice president of research and development, “In addition to being an internationally renowned researcher, Dr. Yu has the entrepreneurial drive to bring desperately needed technology to patients.”

Source: University of Maryland Baltimore

IDEV Technologies, Incorporated (IDEV), an innovative leader in the development and commercialization of minimally invasive medical technologies, announced U.S. Food and Drug Administration (FDA) 510(k) clearance to market the SUPERA VERITAS Transhepatic Biliary System.

SUPERA VERITAS is the next-generation delivery system for IDEV’s unique SUPERA® wire interwoven nitinol stent, currently cleared in the U.S. for palliative treatment of biliary strictures produced by malignant neoplasms. The SUPERA VERITAS system is also approved for use in the ongoing FDA-approved IDE trial in the U.S. for treatment of peripheral arterial disease of the superficial femoral artery (SFA). The FDA 510(k) clearance notification was dated October 5, 2010.

“Clearance of the SUPERA VERITAS system represents the culmination of a strong effort to respond to customer needs,” explained Christopher M. Owens, President and CEO of IDEV. “The result is an innovative system that we believe provides us with a significant competitive advantage, and may represent a paradigm shift in how patients are treated.”

The new device provides easier deployment of the Supera stent compared to earlier systems, eliminating multiple steps previously required for preparation and delivery. More importantly, the new system allows operators to place the stent more precisely than before.

“I’ve been deploying the SUPERA stent now for over a year. The high radial force of the stent is particularly suited for biliary strictures. The introduction of the SUPERA VERITAS system is a great complement to an outstanding stent,” stated Mark Garcia, MD, Chief of Interventional Radiology at Christiana Care Health System in Wilmington, Delaware.

Gino Sedillo, MD, FACC of Bradenton Cardiology Center in Bradenton, Florida, is an investigator in the SFA trial. He commented, “I’ve seen the SUPERA VERITAS system demonstrated, and was able to use it myself during a visit to Park Hospital in Leipzig, Germany. The delivery steps have not only been greatly simplified, but there is also improved reliability and predictability of stent placement. I look forward to incorporating the new delivery system into the ongoing prospective trial.”

Don Jacobs, MD, a vascular surgeon at St. Louis University Hospital in St. Louis, Missouri, was asked to provide feedback on the new delivery system while in Leipzig, Germany and stated, “I was very impressed with the accuracy of the VERITAS system, and appreciated how it improved the ease of delivery of the SUPERA stent. It represents a truly significant advance and adds significantly to an outstanding product package.”

Commercial availability of the SUPERA VERITAS Transhepatic Biliary System is planned for the first quarter of 2011.

Source: IDEV Technologies, Incorporated

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced it will display a number of ground breaking technologies and clinical solutions from the company’s Cardiac Rhythm Management and Atrial Fibrillation Divisions at the 3rd annual Asia-Pacific Heart Rhythm Society Scientific Session (APHRS), which is held in conjunction with the 6th annual Asia-Pacific Atrial Fibrillation Symposium. The new products and virtual reality technology highlight the company’s commitment to providing a comprehensive learning platform alongside the most technologically advanced portfolio of therapies and devices for the treatment of cardiac arrhythmias.

Commenting on the company’s presence at APHRS, Sang Yi, vice president and general manager of St. Jude Medical Asia-Pacific, said, “St. Jude Medical is pleased to once again be the largest sponsor of the annual APHRS congress to support the advancement of these important, life-saving technologies to patients in the region. We recognize the importance of the Asia Pacific market and continue to invest in it by broadening our product portfolio, establishing a strong presence in the region with new manufacturing and education facilities, and investing in ongoing education to help physicians develop the knowledge and skill needed to enhance patient care.”

Products and technologies will be on display at St. Jude Medical booth S01 and at the St. Jude Medical Technology Suite in the Ocean View Room (Level 5) at the International Convention Center (ICC), Jeju Island in the Republic of Korea. Products will be on display from 8 a.m. to 6 p.m. on Thursday, Oct. 28, Friday, Oct. 29 and Saturday, Oct. 30. The highlights include:

Introduction of Virtual Reality Simulations

Now available for the first time in the Asia Pacific market, the virtual reality simulator is St. Jude Medical’s latest investment in education and training, and is designed to help enhance patient care. It offers physicians access to advanced cardiac care techniques and best clinical practices using the latest St. Jude Medical technology to simulate procedures, such as implanting a left ventricular (LV) lead or performing a transseptal puncture. From guiding catheters through the vessels, to optimally placing a lead in a human-size model, the simulator allows physicians to become familiar with St. Jude Medical products.

The virtual reality simulation sessions will take place by appointment in the St. Jude Medical Advanced Learning Center booth on Thursday, Oct. 28 and Friday, Oct. 29 from 9 a.m. to 4:30 p.m. and on Saturday, Oct. 30 from 9 a.m. to noon.

After APHRS, the simulators will be permanently housed in the newly opened St. Jude Medical Advanced Learning Center Asia Pacific in Beijing, China.

Cardiac Rhythm Management Division

Unify(TM) CRT-D and Fortify(TM) ICD: The Unify(TM) cardiac resynchronization therapy defibrillator (CRT-D) and Fortify(TM) implantable cardioverter defibrillator (ICD) are a new family of devices that feature advanced battery technology and circuitry that allow for the smallest device footprint in the industry and rapid charge times, without any compromise in device longevity or power. Unify(TM) and Fortify(TM) have 45J of stored energy and can deliver 40J, the highest energy of any ICD available today. This high energy capacity gives these devices the ability to provide a greater safety margin, which could increase the chances that therapy will be successful for patients who may need more energy to correct their heart rhythm. The products are approved for use in the U.S., Europe, Australia, New Zealand, and Hong Kong.

Promote Quadra(TM) CRT-D and Quartet(TM) left ventricular pacing lead: The Promote Quadra CRT-D is the industry’s first quadripolar pacing system, which offers physicians the ability to more effectively and efficiently manage the ever-changing pacing needs of patients with heart failure. It integrates multiple pacing configurations and features that enable physicians to optimize the system at implant and follow-up, as well as better manage common complications without having to surgically reposition the lead. The Quartet(TM) left ventricular pacing lead, used as part of the Promote Quadra system, features four pacing electrodes on the left ventricular lead – enabling up to 10 pacing configurations. The products are approved for use in Europe and Hong Kong.

Other products on display include the Current(TM) Accel ICD and Promote Accel CRT-D, Accent(TM) Pacemaker and Anthem(TM) CRT-P, and the Merlin.net(TM) Patient Care Network (PCN).

Atrial Fibrillation Division

Therapy(TM) Cool Flex(TM) Ablation Catheter: The ablation catheter is the industry’s first to have a fully-irrigated and flexible tip, which is indicated to treat abnormal heart rhythms (also called arrhythmias). Compared to catheters with rigid tip design, the Therapy Cool Flex catheter tip has been designed with the intention to conform better to a greater range of cardiac tissue anatomy using various angles of approach. The Therapy Cool Flex is approved for use in Europe, Australia and New Zealand.

EnSite Velocity(TM) Cardiac Mapping System: The next-generation of the industry-leading EnSiteTM System is designed to help physicians more efficiently diagnose abnormal heart rhythms. The EnSite Velocity System creates a three-dimensional (3-D) model of the patient’s heart, allowing physicians to visualize their patient’s unique anatomy with great detail. Physicians can then quickly locate the source of the arrhythmia and formulate a treatment strategy. The new platform is customizable, providing the flexibility to better integrate current and future technology. The EnSite Velocity is approved for use in the U.S., Europe, Japan, Australia, Korea, India, Hong Kong, Singapore, Thailand and Malaysia.

EnSite Derexi(TM) module: The EnSite Derexi provides improved electrophysiology (EP) lab efficiency and workflow by enabling communication between the EnSite Velocity Cardiac Mapping System and the EP-Workmate(TM) Recording System. The EnSite Derexi module enables procedural data (including relevant images, waveforms and other clinical data) and patient medical history information to be shared between the mapping and recording system to produce a single, synchronized patient record of a procedure. The EnSite Derexi is approved for use in the U.S., Europe, Hong Kong, India, Malaysia, Taiwan, Thailand, Australia and New Zealand.

Other products on display include the EP-Workmate(TM) Recording System, AFocus II(TM) Diagnostic Catheter, Agilis NxT(TM) Steerable Introducer, Therapy(TM) Cool Path(TM) Duo Irrigated Ablation Catheter, and the Cool Point(TM) Irrigation Pump.

Source:
APHRS
St. Jude Medical

The European Commission presented its report on the reprocessing of medical devices before the European Parliament yesterday. Speaking before the Committee on the Environment, Public Health and Food Safety (ENVI), the Commission highlighted three major risks related to the reprocessing of medical single use devices: remaining contamination, persistence of chemical substances used during the reprocessing process, and the alteration of performances due to the reprocessing. Eucomed, the European medical technology industry association, encourages the European Commission to propose legal measures that will secure the highest level of safety for patients.

The Commission gave an overview of the current attitudes of Member States with regards to the reprocessing topic and concluded that the majority does not have any special legislative measure in place. The Commission added that where legislative measures do not exist, this is generally interpreted as an interdiction.

The Vice-President of the European Parliament, Dagmar Roth-Behrendt, and Member of the European Parliament, Thomas Ulmer, emphasized the urgent need for legislative action. Dr. Ulmer suggested that possible connection between this issue and hospital acquired infections which are causing 1500 deaths per year in Europe, should be investigated.

John Wilkinson, Chief Executive of Eucomed, said: “Eucomed is in close dialogue with the European Commission because it is an important issue for patient safety and industry practice. Reprocessing of single use devices puts patients at risk and can create a two-speed healthcare system in Europe. Companies producing single use devices do so to respond to a request from users to reduce cross contamination risks. Putting aside the economic, environmental and legal points, what about the ethical aspects associated with the reprocessing of single use devices? If you were a patient, wouldn’t you want to know whether you were being treated with a new single use device or a single use device that has been used more than once on more than one patient? ”

Source:
Eucomed

PLEASANTON, Calif., Oct. 25 /PRNewswire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food & Drug Administration (FDA) has approved the real-time PCR COBAS® TaqMan® HCV Test, v2.0. Clinical research organizations have depended on COBAS® TaqMan® technology to support hepatitis C pharmaceutical trials and development. This new test will help clinicians to more confidently and effectively monitor their patients, and to improve treatment outcomes.

“This HCV quantitative test is key to measuring the effectiveness of many antivirals that are currently in clinical development for the treatment of hepatitis C,” said Teresa Wright, M.D., Chief Medical Officer of Roche Molecular Diagnostics. “Roche is committed to providing complete diagnostic and treatment solutions for this important global disease.”

About COBAS® TaqMan® HCV Test, v2.0 For Use With High Pure System

Designed for use with the High Pure System Viral Nucleic Acid Kit, the COBAS® TaqMan® HCV Test, v2.0 is intended to quantify the amount of hepatitis C viral RNA in human plasma or serum of HCV infected individuals. The test incorporates a manual specimen preparation and the COBAS® TaqMan® 48 Analyzer for automated amplification and detection. Roche now offers HCV viral load test for both automated and manual specimen preparation methods; further demonstrating Roche’s commitment in providing workflow options and flexibilities for the diverse needs of laboratories. The test system benefits from the proven contamination controls designed into all COBAS® TaqMan® assays, including built-in Roche-proprietary AmpErase enzyme.

About Hepatitis C

According to the Centers for Disease Control, Hepatitis C virus (HCV) infection is the most common chronic blood borne infection in the United States; approximately 3.2 million persons are chronically infected.

Each year in the U.S. approximately 8,000 – 10,000 people die from hepatitis C-related liver disease. An estimated 3.2 million persons in the United States have chronic hepatitis C virus infection. Most people do not know they are infected because they don’t look or feel sick. However, approximately 75 – 85% of people who become infected with hepatitis C virus develop infection.(1)

Hepatitis C infections can range in severity from a mile of “acute” illness lasting a few weeks to a serious, lifelong or “chronic” illness. For most people, acute infection leads to chronic infection. Chronic hepatitis C infection is a serious disease that can result in long-term health problems, including liver damage, liver failure, liver cancer, or even death. Hepatitis C is the leading cause of cirrhosis and liver cancer and the most common reason for liver transplantation in the United States.

Hepatitis C virus is passed when infected blood enters the body of someone who is not infected. People can be infected by sharing contaminated needles, high risk sex with an infected partner, and from an infected mother to her infant during pregnancy and childbirth.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2009, Roche had over 80,000 employees worldwide and invested almost 10 billion Swiss francs in R&D. The Group posted sales of 49.1 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.

(1) U.S. Centers for Disease Control. http://www.cdc.gov

All trademarks used or mentioned in this release are legally protected by law.

SOURCE Roche