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Swine Flu Media Bulletin Spread And Extent Of The Outbreak (Information As At 5pm On 27 May), Wales
- 0 confirmed cases in Wales.
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Airway Spheres Created By Duke Scientists To Study Lung Diseases
Using both animal and human cells, Duke University Medical Center scientists have demonstrated that a single lung cell can become one of two very different types of airway cells, which could lead to a better understanding of lung diseases.
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Health Subcommittee Considers Bill To Eliminate Pre-Emption For Medical Devices
The House Energy and Commerce Health Subcommittee on Tuesday heard testimony on the Medical Device Safety Act of 2009 (HR 1346), which would allow consumers to sue medical device manufacturers in state courts, CQ HealthBeat reports. The bill responds to last year"s Supreme Court ruling that says medical devices with FDA pre-marketing approval can be pre-empted from lawsuits under state law, in accordance with the Medical Device Amendments of 1976. Rep. Frank Pallone (D-N.Y.), who introduced the bill, said that the 2008 Supreme Court ruling "ignor[ed] congressional intent" by providing blanket immunity for medical device makers. According to Rep. John Dingell (D-Mich.), a co-sponsor of the bill, the original 1976 law sought to grant regulatory authority to FDA for medical devices, but it did not aim to eliminate state liability. Committee Chair Rep. Henry Waxman (D-Calif.), another co-sponsor, said last year"s ruling already has caused 1,400 injury cases to be thrown out of court, adding that the threat of litigation provides manufacturers with additional safety incentives. David Vladeck -- a law professor at Georgetown University Law Center who testified at the hearing -- added that immunity from lawsuits "removes incentive to manufacturers to fix devices quickly and get defective devices off the market."Rep. Nathan Deal (R-Ga.) said the class of device that must obtain pre-marketing approval -- which includes pacemakers and replacement heart valves -- represents only 2% of all approved medical devices each year. Rep. Michael Burgess (R-Texas) added that the measure could create an inconsistent system that allows both FDA experts and jurors in various states to make decisions on medical device safety standards. In addition, Rep. Joe Pitts (R-Pa.) cautioned that the bill might encourage manufacturers to limit distribution of their devices to certain states (Kim, CQ HealthBeat, 5/13). Related Editorial
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Terumo Heart, Inc. Reaches Clinical Milestone As The 100th Patient Worldwide Receives The DuraHeart(TM) Left Ventricular Assist System

Terumo Heart Inc., a wholly owned subsidiary of Terumo Corporation, announced reaching a critical milestone in the worldwide expansion of its DuraHeart(TM) Left-Ventricular Assist System (LVAS) as the 100th patient was treated by Latif Arusoglu, MD and Michiel Morshuis, MD, cardiothoracic surgeons at the Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center NRW, University Hospital of the Ruhr-University of Bochum in Bad Oeynhausen, Germany. During the weeks leading up to this major milestone, heart failure centers in Europe and the U.S. were kept up to date in the progress toward treating the one hundredth patient. In a fitting example of the successful ongoing global expansion of the DuraHeart LVAS program, the distinction for the 100th implant came in rapid succession as three centers across two continents performed implants. In less than 20 hours, Yoshifumi Naka, MD, PhD, director of cardiac transplantation at NewYork-Presbyterian Hospital/Columbia University Medical Center and associate professor of surgery at Columbia University College of Physicians and Surgeons, treated the 99th patient; Drs. Arusoglu and Morshuis treated the 100th patient; and David A. Dean, MD, Head, Section of Thoracic and Cardiac Transplantation, Gerald McGinnis Cardiovascular Institute, Allegheny General Hospital, treated the 101st patient. "Our institution has implanted more of these devices than any other institution worldwide so we were very happy to be the site for the 100th patient implant," said Professor Jan Gummert, MD, cardiothoracic surgeon and Director of the Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center NRW, University Hospital of the Ruhr-University of Bochum in Bad Oeynhausen, Germany. "The DuraHeart LVAS, which offers the latest technology, is both highly effective and very reliable. We believe the device is an excellent tool to treat our end-stage heart failure patients who are no longer capable of pumping enough blood to allow normal activity, and enables the patient to have a very good quality of life." The DuraHeart LVAS is the first, third-generation rotary blood pump designed for long-term patient support that incorporates a centrifugal flow rotary pump with an active magnetically levitated impeller featuring three position sensors and magnetic coils that optimize blood flow, while minimizing device wear and tear. The DuraHeart LVAS is currently being studied in the DuraHeart Pivotal U.S. Trial for Bridge-to-Transplant, a multi-center, prospective, non-randomized study, involving 140 patients in up to 40 centers nationwide. The study will evaluate the safety and efficacy of the device in helping to sustain patients awaiting heart transplant who are at risk of death due to end-stage left ventricular failure. The DuraHeart LVAS carries a CE Mark and is currently available for sale in European countries. Additionally, the company has completed clinical trial enrollment for this device in Japan. "As the case drew closer, it was exciting to know that multiple centers globally had patients scheduled for implantation, but in the end, the time zone difference meant that our colleagues in Germany would implant before us and we did patient number 101 within a matter of hours," said Dr. Dean. "What matters most is that we are able to bring this state-of-the-art, life-sustaining technology to our patients awaiting heart transplant who are at risk of death due to end-stage left ventricular failure. We are excited to offer this leading-edge technology as one of the first centers in the country to participate in the DuraHeart Pivotal U.S. Bridge-to-Transplant trial." The DuraHeart LVAS features a small centrifugal pump that is implanted in a small pocket created underneath the abdominal muscle. When the pump is activated, the impeller is levitated by the electromagnets and its position is precisely controlled by position sensors to keep it centered within the blood chamber. Permanent magnets couple the impeller to the motor so when the motor spins, it causes the impeller to rotate and pump blood from the heart to the body. In its weakened state, the heart is not strong enough to supply sufficient blood for normal activities. The DuraHeart supplements the natural flow by pumping blood from the left ventricle to the aorta, increasing total flow to normal levels. The development of the DuraHeart LVAS began in 1995 at Research & Development Center, Terumo Corporation, in Japan as a part of a Japanese National Project funded by the Ministry of International Trade and Industry. The project was moved from Japan to Ann Arbor, Michigan for product realization in 2000. The first human clinical trial was launched in 2004 in Europe and CE-mark was granted in 2007. "It is truly gratifying to participate in the development and significant progress of the DuraHeart System that everyone at Terumo Heart and each one of our clinical partners has worked so hard to achieve," said Chisato Nojiri, M.D., Ph.D., Chairperson and Chief Medical Officer, Terumo Heart, Inc. "The implanting of the 100th patient is an exciting point along the road to bringing this important, next-generation technology to the global market, and the implanting of three devices in such a short period gives testimony to its benefit and the commitment and belief of cardiothoracic surgeons in Europe and the U.S. in its potential. We continue to receive excellent feedback from physicians and are working toward completion of enrollment and ultimately commercial use of the DuraHeart LVAS in the US." About Heart Failure More than 22 million people suffer from heart failure worldwide with approximately one million new patients diagnosed annually. In the setting of an aging global population, heart failure is the number one reason for hospitalization. The most severely ill patients need heart transplants in order to recover. More than 8,000 people worldwide are on the list of eligible candidates for heart transplants annually, but less than 3,000 will receive a transplant each year. A large number of people who suffer from severe heart failure do not qualify for transplantation due to other health issues. An alternative for these patients is access to artificial mechanical assist devices. Left Ventricular Assist Systems are a type of mechanical circulatory device specifically designed to improve the quality of life of the patients waiting for donor hearts, as well as those who are ineligible for a heart transplant. About Terumo Heart, Inc. Terumo Heart, Inc. is a U.S. subsidiary of Terumo Corporation with headquarters and manufacturing facilities in Ann Arbor, Michigan. The company"s focus is the innovation and introduction of products to improve the quality of healthcare for heart failure patients. Terumo Corporation, located in Tokyo, Japan, is a leading developer, manufacturer and global marketer of a wide array of medical products. DuraHeart is limited to investigational use only in the United States, and is CE marked in Europe. Terumo Heart, Inc.


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