Thoratec Corporation has introduced the HeartMate XVE LVAS (left ventricular assist system), an enhanced version of the HeartMate VE device that was the subject of the highly successful REMATCH trial.

The results of the trial demonstrated clinically meaningful survival benefits and improved quality of life for end-stage congestive heart failure patients supported by the device.

The newly introduced XVE version of the device, which is now being used in bridge to transplant patients, reflects technological advances based on the REMATCH experience, according to D. Keith Grossman, president and chief executive officer of Thoratec.

"These device enhancements are designed to improve patient comfort, ease implantation and provide for longer device life. "We have received FDA approval to use the XVE for the approved bridge to transplant indication. If we receive approval for our destination therapy PMA (PreMarket Approval) Supplement based on the REMATCH trial currently before the FDA, we plan immediately to file a separate PMA Supplement seeking approval to include the XVE enhancements in the treatment of that patient population as well," he said.

Changes included in the HeartMate XVE include a longer, smaller diameter and more flexible lead designed to improve patient comfort and provide more flexibility for surgeons to accommodate larger patients. In addition, a rotating tunneling bullet was added to ease implantation and facilitate tunneling of the driveline through the exit site on the patient. Other improvements include graft redesigns to reduce kinking and battery module improvements to increase battery life.

The data from the REMATCH study shows that survivability rates were particularly dramatic for patients younger than 60 years of age, with a one-year survival rate of 74 per cent versus only 33 per cent for the control arm. These reported outcomes begin to approach the 80 per cent one-year survival rate for heart transplant patients.

REMATCH stands for Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure. The trial compared patients randomized to the HeartMate VE with those treated with optimal medical management involving maximum drug therapy, diet and exercise. These patients were either too sick or too old to qualify for a heart transplant. In addition to patient survival, the study was designed to collect data on quality of life, cost of care and adverse events during the treatment. The study was a collaboration among the National Institutes of Health, Columbia University and Thoratec and is being coordinated by Columbia's International Center for Health Outcomes and Innovation Research (InCHOIR).