The Food and Drug Administration has approved two electric left ventricular assist systems (LVAS) for sale in the United States.
On September 29, the FDA gave the go-ahead to Baxter Healthcare Corporation's Novacor LVAS and Thermo Cardiosystems' HeartMate LVAS. Both systems work as a bridge to transplantation and allow patients to leave the hospital and resume daily activities while awaiting a donor heart.
"I am now able to offer relatively normal life to some patients who would otherwise be dead," said Robert Kormos, MD, a principal investigator in the clinical trials testing Novacor. Dr. Kormos, director of the Artificial Heart Program and Adult Cardiac Transplantation at the University of Pittsburgh, said that more than 90% of patients are bedridden prior to receiving the Novacor system, but most patients can walk a few days after Novacor is implanted.
The Novacor LVAS has been marketed in Europe since 1994 as a bridge to transplant and as a long-term alternative to therapies such as chronic drug treatment and heart transplantation.
Clinical trials of HeartMate began in 1991 and were carried out at 25 transplant centers in the United States. "Despite all patients being at imminent risk of death prior to receiving the HeartMate system, more than half left the hospital to live at home, go back to school, or to return to normal daily activities," Thermo Cardiosystems said in a statement.
The company also makes a pneumatic LVAS, which was approved by the FDA in 1994. Both the pneumatic and electric HeartMate systems are approved for use in Canada, Europe, and parts of Asia. "Company research demonstrates that the Heart Mate systems more than double the probability that heart-transplant candidates will survive long enough to receive a donor heart," Thermo Cardiosystems said.
For Your Information:
Novacor
A printed news release, video news release, and background information that includes patient profiles and a list of Novacor's clinical centers worldwide are available at www.baxter.com/novacor.HeartMate
At www.thermo.com/news.html, click on Press Releases and then Thermo Cardiosystems.
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