The Heart Center at Newark Beth Israel Medical Center was one of the nation’s leading centers to participate in the clinical research trial that resulted in the recent FDA approval for use of a ventricular assist device (VAD) for destination therapy. The device is designed to take over the pumping action of a diseased heart in people who have advanced heart failure and who are not eligible for a heart transplant.
Thoratec Corporation, maker of the HeartMate II, announced last week that it received approval from the FDA for use of the device as destination therapy. Implanted in the chest, the VAD can extend patients’ lives while significantly improving their quality of life. The same device was approved by the FDA in 2008 for use as a bridge to transplant.
New Jersey residents have had access to the benefits of the device since 2006 when the Saint Barnabas Heart Center at Newark Beth Israel Medical Center was the only hospital in the state selected to participate in the HeartMate II Destination Therapy clinical trial. Newark Beth Israel was one of the top enrolling sites in the nation.
“Approval of the HeartMate II for long-term therapy offers a great alternative to transplant,” said Mark J. Zucker, MD, JD, Director of the Heart Failure Treatment and Transplant Program at Newark Beth Israel Medical Center. “When age or other health issues prevent patients from qualifying for a heart transplant, the newest generation of VADs can extend and improve their lives for many years.”
“One of the advantages of the HeartMate II is its continuous flow design,” said Margarita Camacho, MD, Surgical Director of Cardiac Transplant and Mechanical Assist Devices at Newark Beth Israel Medical Center and Principal Investigator of the HeartMate II Destination Therapy clinical trial. “Powered by a rotary pump, it is designed to have a much longer functional life and it operates more simply and quietly,” she explained.
Since placing New Jersey’s first implantable ventricular assist device in 1993, the team’s expertise has allowed Newark Beth Israel to offer virtually all FDA-approved and investigational implantable VADs for more than 16 years. It remains one of the nations’ premier centers for implantation of the most advanced devices, implanting a total of more than 80 devices in 2008 and 2009—more than any other program in New Jersey. Newark Beth is also among an elite group of hospitals to receive VAD for Destination Therapy Certification from The Joint Commission that ensures safe, high quality care and services in this highly specialized field.
Newark Beth Israel Medical Center has a distinguished history in the field of cardiology. Its pioneering physicians performed the first early coronary bypass procedures as well as the first heart transplant in New Jersey. Their work in the development and use of pacemakers is world renowned. Building on that legacy, Newark Beth Israel’s nationally respected cardiac physicians, surgeons and researchers continue to make significant advances in cardiac care.
At the Saint Barnabas Heart Center at Newark Beth Israel Medical Center, New Jersey residents have access to one of the nation’s finest and most comprehensive cardiovascular programs that was ranked among the nation’s 50 best in Heart and Heart Surgery by U.S.News & World Report’s America’s Best Hospitals 2009-10. Highly specialized care includes minimally invasive and robotic-assisted cardiac procedures, state-of-the-art technology that provides astounding images of the heart for more precise diagnosis, and the latest generation of ventricular assist devices designed to take over the pumping action for a diseased heart. Its heart transplant program remains among the most active in the country, ranking ninth in the nation by volume, with short- and long-term graft survival rates that consistently exceed national benchmarks.
Date: January 25, 2010
Contact: Caren Malone
Public Relations Department
Saint Barnabas Health
Care System
973-322-4017, cmalone@barnabashealth.org
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