PLEASANTON, Calif., May 22 /PRNewswire-FirstCall/ -- Thoratec Corporation , a world leader in products to treat cardiovascular disease, today said that it has completed enrollment in the randomized portion of the Destination Therapy (DT) arm of its Pivotal trial for the HeartMate II by enrolling 200 patients on a randomized basis as called for in the trial protocol.
As the company announced May 3, it has received approval from the FDA for a Continued Access Protocol (CAP) to enroll an additional 60 patients in the DT arm. The company also recently received a CAP to enroll an additional 60 patients in the Bridge-to-Transplantation (BTT) arm of the trial. The CAP patients in both arms will be enrolled and followed under the original protocols of their respective clinical trials.
"We are delighted to have achieved this important milestone in our program for this next-generation device. We completed this arm of the trial in slightly more than two years after initiating enrollment in the trial, benefiting from increasingly strong enrollment levels over the past nine months," said Gary F. Burbach, president and chief executive officer of Thoratec. "With the completion of the DT arm, and the BTT arm last year, we believe this represents the fastest enrolling trial in the history of VAD (Ventricular Assist Device) technology," he added.
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, the HeartMate II is designed to have a much longer functional life than pulsatile 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 hemodynamic restoration therapy-developing products to treat cardiovascular disease. The company's product line includes the Thoratec(R) VAD and HeartMate LVAS with more than 11,000 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/.
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 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.
