New Use for Thoratec’s HeartMate Approved

Thoratec Corp. on Wednesday won U.S. approval to sell an implantable heart device as a permanent treatment for patients too sick for transplants, opening a new market for the product.

Thoratec already sells the HeartMate for use in heart failure patients awaiting transplants. The device costs about $60,000 to $70,000 and is too large for implantation in many women and some men, said Wedbush Morgan Securities analyst Keay Nakae.

Thoratec, which is based in Pleasanton, Calif., is racing with Arrow International Inc. and World Heart Corp. to develop smaller and less expensive products that do the same job, helping the heart pump oxygen-rich blood out to the body, Nakae said.

Doctors will be more likely to use later, improved versions of the device for patients, he added.

The new HeartMate use “is a great first step, but you are going to need better second-generation devices,” Nakae said.

The approval by the Food and Drug Administration may raise HeartMate’s 2003 sales by about $10 million to $92 million, he said. Revenue may be higher if the U.S. government’s Medicare plan for the elderly pays for the new use of the device, he said.

Thoratec said it expects Medicare to issue guidelines for reimbursement of permanent HeartMate use in the second half of 2003.

HeartMate is about 4 inches in diameter and 2 inches thick. It weighs more than 2 pounds. The batteries for the device remain outside of the patient’s body, carried in holster-like garments.

About 2 million to 3 million Americans have heart muscle so damaged that the organ no longer can pump blood adequately. Some of the patients can be treated with medicines and only the most seriously ill qualify for HeartMate.

Shares of Thoratec fell 7 cents to $9.24 on Nasdaq.