PLEASANTON, Calif., April 16, 2015 /PRNewswire/ -- Thoratec Corporation (NASDAQ: THOR), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, commented on HeartMate II clinical data presented as part of the ENDURANCE destination therapy trial today at the 35th Annual Meeting and Scientific Sessions of the International Society for Heart and Lung Transplantation (ISHLT 2015) in Nice, France.
"We are pleased that the ENDURANCE study adds to the significant body of evidence confirming the benefit of HeartMate II for long-term support of advanced heart failure patients deemed ineligible for transplant, including two-year survival of 68%, the highest level ever reported in a destination therapy trial for any device," said D. Keith Grossman, President and Chief Executive Officer.
ENDURANCE study data continue to demonstrate HeartMate II's survival and quality of life benefits for destination therapy patients. Two-year survival of 68% showed continued improvement compared with the HeartMate II destination therapy clinical trial and post-approval study experience, with the significant majority of patients improving from advanced heart failure to NYHA Class I or II status. Overall adverse event rates remained consistent with prior experience, with a notably low rate of neurological events, including stroke. Pump exchange rates for HeartMate II were higher in ENDURANCE than during the original HeartMate II destination therapy study, a previously reported finding that is the subject of the ongoing PREVENT trial as part of an overall effort to continuously improve outcomes with HeartMate II.
"HeartMate II has developed a well-established profile for long-term support, with nearly 8,000 ongoing patients, including some living with HeartMate II for over ten years. We look forward to continuing to develop the currently under-penetrated destination therapy market in partnership with leading VAD programs throughout the world," added Mr. Grossman.
ENDURANCE is a prospective, randomized, multi-center, controlled trial in the U.S. that enrolled 150 HeartMate II patients between August 2010 and May 2012 to serve as the control cohort evaluating LVAD devices for advanced heart failure patients ineligible for heart transplantation. Final results based on two-year follow-up were presented today.
Thoratec is a world leader in therapies to address advanced-stage heart failure. The company's products include the HeartMate II® LVAS (Left Ventricular Assist Systems) and Thoratec® VAD (Ventricular Assist Device) with more than 20,000 devices implanted in patients suffering from heart failure. Thoratec also manufactures the CentriMag® and PediMag®/PediVAS® product lines. Thoratec is headquartered in Pleasanton, California. For more information, visit the company's website at http://www.thoratec.com.
Thoratec, the Thoratec logo, HeartMate and HeartMate II are registered trademarks of Thoratec Corporation. CentriMag and PediMag are registered trademarks of Thoratec LLC, and PediVAS is a registered trademark of Thoratec Switzerland GmbH.
The preceding paragraphs contain forward-looking statements within the meaning of Sections 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, "believes," "views," "expects," "should," "hopes," "could," "will," "estimates," "potential," 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 regulatory approvals, the growth of existing markets for our products, customer and physician acceptance of Thoratec products, the effects of international and FDA regulatory requirements, our ability to address quality issues adequately and on a timely basis without a resulting recall of products or interruption of manufacturing or shipment of products, 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, quarterly reports on Form 10-Q, current reports on Form 8-K and other 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.
SOURCE Thoratec Corporation