Healthcare Industry News: vascular access
News Release - May 16, 2006
Thoratec Receives FDA Approval of Continued Access Protocol for Bridge Arm of Its HeartMate(R) II Pivotal TrialApproval Allows for Enrollment of up to an Additional 90 Patients
PLEASANTON, Calif., May 16 (HSMN NewsFeed) -- Thoratec Corporation (Nasdaq: THOR ), a world leader in products to treat cardiovascular disease, today said that the FDA has approved an IDE (Investigational Device Exemption) supplement that allows enrollment of up to an additional 90 patients in the Bridge-to-Transplantation (BTT) arm of the company's HeartMate II Phase II trial under a Continued Access Protocol (CAP).
The original trial design for the BTT arm called for enrollment of 133 patients. As of April 26, 2006, the company reported that 115 patients had been enrolled in the BTT arm of the study. Patient enrollment under the CAP can begin at the 40 centers participating in the trial once the initial 133 patients are enrolled, subject to IRB approvals at the centers. The CAP patients will be enrolled and followed under the original protocol of the pivotal trial. The addition of these patients will not impact the timing for the company's planned submission of a PMA (PreMarket Approval) Supplement seeking FDA approval of the HeartMate II for the BTT indication.
The HeartMate II is a continuous flow device designed to provide long-term cardiac support for advanced-stage heart failure patients. An implantable LVAS (Left Ventricular Assist System) powered by a rotary pumping mechanism, it is significantly smaller than currently approved devices. 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. It is also smaller and easier to implant than pulsatile devices.
Thoratec Corporation is a world leader in hemodyanmic restoration therapy-developing products to treat cardiovascular disease. The company's product line includes the Thoratec® VAD and HeartMate LVAS with more than 10,000 devices implanted in patients suffering from heart failure. Thoratec's product line also includes the Vectra® VAG (vascular access Graft) for patients undergoing hemodialysis. 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 TNR-416
Some of the preceding paragraphs, particularly but not exclusively those addressing timelines and milestones for clinical trials, contain forward-looking statements within the meaning of Section 27A 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," "projects," "hopes," "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 and the regulatory approval processes. 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 quarterly report on Form 10-Q. 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.
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