FDA Allows Implant of Heart Pump for Transplant Patients

The Food and Drug Administration has approved for experimental use a completely portable heart pump for people awaiting heart transplants, the developer said Thursday.

The Texas Heart Institute in Houston has received FDA permission to implant the pump, developed by Thermo Cardiosystems of Woburn. Known as a ventricular assist device, the pump is intended to take over the work of patients’ badly diseased hearts until organs become available for transplants.

Earlier versions of the machine were air-driven, which meant that patients were tethered to huge consoles. The new model is battery powered and patients will be able to carry their power supply in a shoulder holster, allowing them freer movement.

“This is clearly one of the most important milestones we have achieved in our 25 years of research and development,” said Victor L. Poirier, president of the company.

Doctors at the Heart Institute have already tested an air-driven version of Thermo Cardiosystems’ heart pump. A Heart Institute spokesman said the first implant will likely occur in February or March. A patient has not yet been selected.

Dr. O. H. Frazier, director of cardiac transplants at the institute, said none of their patients suffered strokes as a result of being on the pumps. Strokes have been a major complication of mechanical hearts because they prompt the blood to form clots that lodge in the brain.

The new pump will take over the work of the left ventricle, the heart’s main pumping chamber. The device is implanted in the abdomen, just below the diaphragm, and is powered by a small electric motor.

Thermo Cardiosystems Inc., based in Woburn, is a subsidiary of Thermedics Inc. and Thermo Electron Corp.