FDA Approves Destination Therapy Device for Heart Failure

Heart failure patients in upstate New York and across the country have a new option that has demonstrated significant survival rate results. The FDA in January approved HeartMate II, the next generation of HeartMate left ventricular assist devices, for destination therapy. The URMC Program in Heart Failure and Transplantation is currently the only provider in upstate New York implanting the device.

HeartMate II, an axial flow device produced by Thoratec Corp. that earned FDA approval in 2008 for bridge-to-transplantation, is logging dramatic survival rate statistics. In a recent two-year study, survival was 58 percent for HeartMate II patients versus 24 percent for the HeartMate XVE patients. By contrast, in the REMATCH study (Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure), the survival rate for heart failure patients randomized for not receiving a left ventricular assist device at 24 months was zero.

In addition to being longer-lasting, HeartMate II is considerably lighter – about 1 pound compared to the nearly 5-pound HeartMate XVE – and also smaller in size, which makes it possible to implant the HeartMate II in smaller patients, particularly women whose bodies could not accommodate the larger HeartMate model.

FDA approval makes the device more widely available to heart failure patients who do not qualify for transplant because of other health problems. “HeartMate II is a significant leap in mechanical support devices and is bringing us closer to the ‘heart on a shelf’ device that we have been working toward,” said H. Todd Massey, M.D., surgical director of the URMC Program in Heart Failure and Transplantation and director of the Artificial Heart Program.

“The device is appropriate for advanced medically refractory heart failure patients,” Massey said. “Patients who receive HeartMate II can live longer, more productive lives.”

URMC was involved in initial clinical trials of the HeartMate II in which the device achieved statistically superior results over the XVE. Survival rates were significantly higher for HeartMate II patients who also remained free from disabling stroke or the need for reoperation to replace or repair the pump. URMC is the only place in upstate New York where patients can have the device implanted.

URMC is a Joint Commission Certified Ventricular Assisted Devices Center. This certification is new to the Joint Commission in the last two years.

For more information or to refer a patient, call the URMC Program in Heart Failure and Transplantation at (800) 892-4964 or (585) 273-3760, or visit www.mystrongheart.com.