FDA Approves HeartMate II Mechanical Heart Pump for Heart-Failure Patients Waiting for Organ Transplantation
Clinical Research by NewYork-Presbyterian Hospital/Columbia University Medical Center and Other Centers Instrumental to Approval
Apr 25, 2008
Heart failure patients at NewYork-Presbyterian Hospital/Columbia University Medical Center were among the first to be implanted with the HeartMate® II LVAS (Left Ventricular Assist System) — a miniature mechanical pump that helps weak hearts pump blood — that has now received approval by the FDA as of April 21 for broad use as bridge to transplantation. As part of clinical trials leading to approval, 22 patients received the new device at NewYork-Presbyterian/Columbia — more than any other hospital in the New York area.
Clinical research studies at medical centers, including NewYork-Presbyterian/Columbia, showed the HeartMate II to be safe and effective, with improved quality of life and survival compared with historical norms for heart-failure patients. In addition, the device is designed to be quieter and more durable than other FDA approved devices.
One-eighth the size of the original HeartMate LVAS, the HeartMate II provides continuous blood flow through the circulatory system using only one moving part — a rotary pumping mechanism.
"For patients whose hearts are unable to effectively pump blood due to severe heart failure, this remarkable device can help them have active lives as they await a heart transplant," says Dr. Yoshifumi Naka, principal investigator of the clinical research studies and 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.
With around 2,200 donor hearts available annually, there are large numbers of patients with end-stage heart failure placed on heart transplant waiting lists. These patients would be candidates to receive the HeartMate II LVAS as a therapeutic option to sustain them until transplant.
FDA approval was based on one-year follow-up data from the first 194 HeartMate II patients enrolled in the trial. Highlights included:
- Survival to cardiac transplantation, recovery or ongoing on HeartMate II support was 80 percent at six months and 77 percent at one year.
- Eighty-four percent of the patients survived to hospital discharge or transplantation.
- The incidence of major adverse events with comparable definitions — including infections, strokes and bleeding requiring surgery — was significantly lower than what was clinically observed in the previous bridge-to-transplantation study of the HeartMate VE LVAS (HeartMate II's predecessor).
Currently, NewYork-Presbyterian Hospital/Columbia University Medical Center is participating in a clinical trial of HeartMate II as a long-term therapy (also known as destination therapy) that could potentially also serve as a permanent support option for these patients.
HeartMate II is manufactured and marketed by Thoratec of Pleasanton, Calif.
Columbia University Medical Center
Columbia University Medical Center provides international leadership in basic, pre-clinical and clinical research, in medical and health sciences education, and in patient care. The medical center trains future leaders and includes the dedicated work of many physicians, scientists, public health professionals, dentists, and nurses at the College of Physicians & Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. Established in 1767, Columbia's College of Physicians & Surgeons was the first institution in the country to grant the M.D. degree. Among the most selective medical schools in the country, the school is home to the largest medical research enterprise in New York State and one of the largest in the United States. For more information, please visit www.cumc.columbia.edu.
NewYork-Presbyterian Hospital, based in New York City, is the nation's largest not-for-profit, non-sectarian hospital, with 2,242 beds. The Hospital has nearly a million patient visits in a year, including more than 220,000 visits to its emergency departments — more than any other area hospital. NewYork-Presbyterian provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine at five major centers: NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian Hospital/Columbia University Medical Center, Morgan Stanley Children's Hospital of NewYork-Presbyterian, NewYork-Presbyterian Hospital/Allen Pavilion and NewYork-Presbyterian Hospital/Westchester Division. One of the largest and most comprehensive health-care institutions in the world, the Hospital is committed to excellence in patient care, research, education and community service. It ranks sixth in U.S.News & World Report's guide to "America's Best Hospitals," ranks first on New York magazine's "Best Hospitals" survey, has the greatest number of physicians listed in New York magazine's "Best Doctors" issue, and is included among Solucient's top 15 major teaching hospitals. The Hospital's mortality rates are among the lowest for heart attack and heart failure in the country, according to a 2007 U.S. Department of Health and Human Services (HHS) report card. The Hospital has academic affiliations with two of the nation's leading medical colleges: Weill Cornell Medical College and Columbia University College of Physicians and Surgeons.
Belinda Mager 212-305-5587 [email protected]