FDA approves testing of improved heart device

January 05, 1991|By New York Times News Service

The Food and Drug Administration has given a Houston hospital approval to begin experimental use of a portable, battery-powered mechanical device to help a failing heart pump blood until a heart donor can be found.

With the new device, the damaged organ stays in place.

After patients awaiting heart transplants get the pump implanted, they are expected to be freely mobile because they will not be tethered to a cumbersome external console, as with earlier versions of the device and the Jarvik-7 artificial heart.

The FDA has given approval for five machines to be implanted. The first operation is not expected before next month.

Success would mark an important step toward medicine's goal of a totally implantable artificial heart.

The new pump is a left-ventricular assist device, which takes over or boosts the work of a failing left ventricle, the biggest of the four chambers of the heart which pumps oxygen-rich blood to the body.

The device is not a full artificial heart, like the air-driven Jarvik-7, which required patients to be tethered to a large external device.

The maker of the battery-powered pump says it will be the first heart device to keep a patient alive while letting him move about.

The new artificial left ventricle offers the potential of reducing the risk of strokes and serious infections that plagued experiments with the Jarvik-7 artificial heart.

Older air-driven versions of the artificial pump have been used for up to eight months in 33 patients in this country without a single stroke or serious infection, said officials of Thermo Cardiosystems Inc., a subsidiary of Thermedics Inc., which makes the device in Woburn, Mass.

The major difference in the new device is that it is battery-powered, not air-driven.

Dr. Barney Clark, a Seattle dentist who in 1982 was the first recipient of the Jarvik-7 permanent artificial heart in Salt Lake City, died of an infection.

The new Thermedics pump will be implanted in the patient's abdomen, just below the diaphragm, the thin muscle that separates the abdomen and the chest cavities.

A tube from the device will enter the left ventricle of the diseased heart.

Baltimore Sun Articles
Please note the green-lined linked article text has been applied commercially without any involvement from our newsroom editors, reporters or any other editorial staff.