Thoratec Completes Filing Of PMA Seeking Bridge-to-Transplantation Approval For HeartMate(R) II

Main Category: Cardiovascular / Cardiology
Also Included In: Transplants / Organ Donations;  Clinical Trials / Drug Trials
Article Date: 23 Dec 2006 - 0:00 PDT

email to a friend   printer friendly   opinions  

Thoratec Corporation (Nasdaq: THOR), a world leader in products to treat cardiovascular disease, said today that it has completed the submission of its PMA (Pre-Market Approval) seeking bridge-to-transplantation (BTT) approval for its HeartMate II LVAS (left ventricular assist system) by filing the clinical summary and draft final labeling module.

On October 31, 2006, Thoratec announced that it had filed the first two modules of the PMA that addressed all of the supporting engineering and preclinical studies, as well as manufacturing and quality systems. At that time, the company indicated that it would file the clinical module once the necessary number of patients reached the efficacy endpoint and it completed the full analysis of outcomes, adverse events and all other secondary endpoints.

The PMA filing is based on data from 133 BTT patients representing more than 57 years of cumulative support. Days of support ranged from 1-568 days. Enrollment of these 133 patients was completed in May 2006, with 26 centers participating. The company continues to enroll additional BTT patients under a Continued Access Protocol.

"We are delighted to have reached this critical milestone in the HeartMate II BTT clinical trial process," said Gary F. Burbach, president and chief executive officer of Thoratec. "We are encouraged by the positive trial patient experience as has been reported in presentations at a number of leading professional medical meetings. We look forward to a productive dialogue with the FDA about this submission," he continued.

In addition, the company has a separate arm of the Pivotal trial seeking approval for long-term use, or Destination Therapy (DT). Enrollment in that arm is continuing, and as of October 26, 2006, 113 randomized patients have been enrolled in the DT arm. This trial design calls for 200 total patients randomized to the company's HeartMate XVE on a 2-1 basis.

The HeartMate II is a continuous flow device designed to provide long-term cardiac support for advanced-stage heart failure patients. An implantable LVAS powered by a rotary pumping mechanism, it is significantly smaller than currently approved devices, enabling an easier implantation in a broader population of patients. The HeartMate II is designed to have a much longer functional life than other approved devices and to operate more simply and quietly. The device provides blood flow through the circulatory system on a continuous basis with only one moving part.

Thoratec is a world leader in therapies to address advanced stage heart failure. The company's product lines include the Thoratec(R) VAD (Ventricular Assist Device) and HeartMate LVAS with more than 10,000 devices implanted in patients suffering from heart failure. Additionally, its International Technidyne Corporation (ITC) division supplies blood testing and skin incision products. Thoratec is headquartered in Pleasanton, California. For more information, visit the company's web sites at http:///www.thoratec.com or http://www.itcmed.com.

Many of the preceding paragraphs, particularly but not excluding those addressing future performance and growth, contain forward-looking statements within the meaning of Section27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements can be identified by the words "expects," "believes," "could," and other similar words. Actual results, events or performance could differ materially from these forward- looking statements based on a variety of factors, many of which are beyond Thoratec's control. Therefore, readers are cautioned not to put undue reliance on these statements. Investors are cautioned that all such statements involve risks and uncertainties, including risks related to the results of enrollment in and timing of clinical trials including the HeartMate II, regulatory approval processes, the development of new markets, including Destination Therapy, the growth of existing markets for our products, customer and physician acceptance of Thoratec products, and the effects of healthcare reimbursement and coverage policies. Forward-looking statements contained in this press release should be considered in light of these factors and those factors discussed from time to time in Thoratec's public reports filed with the Securities and Exchange Commission, such as those discussed under the heading, "Risk Factors," in Thoratec's most recent annual report on Form 10-K, and as may be updated in subsequent SEC filings. These forward-looking statements speak only as of the date hereof. Thoratec 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.

Thoratec Corporation
http://www.thoratec.com

• Additional
• References
• Citations