PLEASANTON, Calif., Sept. 9, 2014 /PRNewswire/ -- Thoratec Corporation (NASDAQ: THOR), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, announced today that it has begun to enroll patients in the HeartMate III U.S. clinical trial.
“We are excited to continue our recent pipeline progress with the start of the U.S. clinical trial for HeartMate III,” said Gary F. Burbach, President and Chief Executive Officer. “Our innovative U.S. trial design allows for the evaluation of patients for both short-term and long-term support, and we are particularly enthusiastic about the potential for HeartMate III to drive future growth of both the LVAD market and Thoratec,” he added.
HeartMate III is a centrifugal-flow chronic left ventricular assist system. The fully magnetically levitated technology foundation is designed to lower adverse event rates through improved hemocompatibility, while HeartMate III also enhances ease of surgical placement through a compact size. In addition to the current U.S. IDE trial, patient enrollment continues in the HeartMate III CE Mark clinical trial, which began in June.
James Long M.D. Ph.D., Director of INTEGRIS Advanced Cardiac Care and Medical Director of the Nazih Zuhdi Transplant Institute at INTEGRIS Baptist Medical Center in Oklahoma City, Oklahoma performed the first HeartMate III implant in the U.S. Dr. Long and his team have a well-established history of innovation in mechanical circulatory support, including participation in clinical trials for every previous HeartMate technology. “We look forward to further enrollment in this important study for the field, and the opportunity to demonstrate the potential benefits of the unique fully magnetically levitated technology of HeartMate III,” commented Dr. Long. Additionally, Douglas Horstmanshof M.D., Co-Director of INTEGRIS Advanced Cardiac Care at INTEGRIS Baptist Medical Center added, “HeartMate III represents an exciting technology with the potential to advance the treatment of heart failure and improve quality of life for the large number of untreated patients that could benefit from chronic circulatory support.”
The HeartMate III U.S. clinical trial is a randomized non-inferiority study comparing HeartMate III with HeartMate II® and includes a primary endpoint of survival free of device replacement and debilitating stroke. The trial began enrollment in a safety phase under conditional approval from the FDA for 30 patients at five sites. Enrollment will broaden to up to 60 sites following full approval from the FDA based on 30-day follow-up data from the initial safety phase. The first 294 randomized patients will be followed for six months to evaluate a short-term indication such as Bridge-to-Transplantation. The first 366 randomized patients will be followed for 24 months to evaluate a long-term indication such as Destination Therapy. The trial also allows for approximately 600 additional randomized patients to be enrolled beyond the pivotal cohort in order to assess secondary endpoints.
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 and HeartMate III, HeartMate PHP, PVAD, IVAD and Pocket Controller are 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,” “plans,” “projects,” “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 development of new products, including development and clinical trial timing, 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, and the effects of competition. Forward-looking statements contained in this press release should be considered in light 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
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