Thoratec Laboratories Submits Data to Begin Canadian Clinical Trials for Aria CABG -- Coronary Artery Bypass Graft -- Device.

PLEASANTON, Calif.--(BW HealthWire)--Jan. 11, 1999--Thoratec Laboratories Corporation (Nasdaq:THOR), a medical device company, said it has submitted an application to the Canadian government for authorization to begin clinical trials for its prosthetic Aria(tm) CABG (coronary artery bypass graft) device at up to ten Canadian hospitals.

The Canadian clinical trial, when approved, will ultimately enroll 330 patients and is expected to begin at three major centers in British Columbia. The clinical trial is designed to last one to two years following completion of patient enrollment.

Thoratec's Aria CABG device, which incorporates the company's proprietary biomaterial, Thoralon, is initially intended for use in patients undergoing coronary artery bypass surgery with few or no suitable native vessels. It is estimated that up to 20% of all coronary bypass patients fall into this category. During the past five years, the device has been used in 27 patients in Canada and Europe on a compassionate use basis. All surviving patients have remained symptom free during that time.

"Finding an artery or vein of acceptable quality is a key issue with many coronary bypass surgery candidates, particularly if they have undergone prior procedures. The compassionate use experience with the Aria has been very encouraging and we are looking forward to achieving similar results with these clinical trials," said D. Keith Grossman, president and chief executive officer.

"The results from two years of controlled animal trials have also been quite positive and further validate our plans for the Aria graft," Grossman added.

"Assuming a normal review process by the Canadian Bureau of Medical Devices, we would expect to begin enrollment for this trial in the first half of 1999," said Donald A. Middlebrook, vice president, regulatory affairs and quality assurance for Thoratec. "The completion of the Canadian submission is also an important milestone in our strategy to seek approval from the Food and Drug Administration to begin clinical trials with the Aria graft in the U.S. sometime later this year," he added.

Thoratec Laboratories Corporation is engaged in the research, development, manufacture and marketing of medical devices for circulatory support and vascular graft applications, all of which incorporate its proprietary biomaterial, Thoralon. For more information, visit the company's Web site at http://www.thoratec.com.

The portions of this news release that relate to future plans, events or performances are forward-looking statements. Investors are cautioned that all such statements involve risks and uncertainties, including the risks of clinical trials, risks related to government regulatory approval processes, announcements by the company's competitors, rapidly changing technology, an intensely competitive market, and market acceptance of new products. These factors, and others, are discussed more fully in the company's annual report on Form 10-K for the fiscal year ended January 3, 1998, and the company's other filings with the Securities and Exchange Commission. Actual results, events or performance may differ materially. These forward-looking statements speak only as of the date hereof. The company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.