Research Sponsored by NHLBI Results in FDA Approval of Permanent Artificial Heart
The US Food and Drug Administration has approved the first totally implanted artifical heart for patients with advanced heart failure in both of the heart's pumping chambers.
Schmalfeldt: The US Food and Drug Administration has approved the first totally implanted artifical heart for patients with advanced heart failure in both of the heart's pumping chambers. The National Heart, Lung and Blood Institute at the National Institutes of Health supported the research which led to the development of the device, which is intended for patients who are not eligible for a heart transplant and whose life expectancy without the device is only a month. Doctor Daniel Schultz, director of the FDA's Center for Devices and Radiological Health announced the approval during a recent teleconference.
Schultz: Today's approval represents a significant step in the evolution of this important technology, allowing it to come to the marketplace in a way that we feel best serves the needs of the American public. We hope that today's approval will encourage the continued development and refinement of this technology, and in fact we know that investigators are continuing to work on these products and that further refinements will make this product safer and more effective in the future, and hopefully allow it to be used earlier on in the process of heart failure for larger populations.
Schmalfeldt: Since the 1960s, the NHLBI has funded extensive basic research to develop a range of mechanical heart support devices, including the total artificial heart and ventricular assist devices. About five million people in the United States suffer from heart failure, and it contributes to or causes about 300-thousand deaths per year. From the National Institutes of Health, I'm Bill Schmalfeldt in Bethesda, Maryland.
About This Audio Report
Reporter: Bill Schmalfeldt
Sound Bite: Dr. Daniel Schultz
Topic: Heart Disease