Thoratec Receives Approval From FDA For Full Expansion Of HeartMate III™ U.S. IDE Clinical Trial

USA - English

• USA - English

PLEASANTON, Calif., April 2, 2015 /PRNewswire/ -- Thoratec Corporation (NASDAQ: THOR), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, today announced that it received final approval from the FDA to broaden enrollment of the HeartMate III U.S. clinical trial of up to 1,028 patients in up to 60 sites. This was based on the FDA's evaluation of safety data from the first ten HeartMate III implants performed in recent months during a limited enrollment phase at five sites.

"We are very pleased to reach this most recent milestone with our HeartMate III clinical program, along with the increasing enthusiasm for our latest product advancements," said D. Keith Grossman, President and Chief Executive Officer. "Building on our recent success with rapid enrollment in the HeartMate III CE Mark study, we look forward to bringing this differentiated technology to 60 of the most active implanting centers throughout the U.S.," he added.

HeartMate III is a centrifugal-flow chronic left ventricular assist system, utilizing a fully magnetically levitated technology foundation, designed to lower adverse event rates while also enhancing the ease of surgical placement through a compact size. 

Additionally, Thoratec announced that it has named co-principal investigators for the HeartMate III U.S. clinical trial. They are Dr. Mandeep Mehra, Medical Director of the Brigham and Women's Health Heart and Vascular Center, Executive Director of the Center for Advanced Heart Disease, and Professor of Medicine at Harvard Medical School; Dr. Daniel Goldstein, Professor and Vice-Chair of the Department of Cardiothoracic Surgery and Surgical Director of the Mechanical Assistance Program at Montefiore Medical Center; Dr. Nir Uriel, Associate Professor of Medicine and Medical Director of the Heart Failure, Heart Transplant and Mechanical Assist Device Programs of the Division of Cardiology at the University of Chicago; and Dr. Joseph Cleveland Jr., Professor of Surgery and Surgical Director of Cardiac Transplantation and Mechanical Circulatory Support at the University of Colorado Anschutz Medical Center. 

The HeartMate III U.S. clinical trial is a randomized non-inferiority study comparing HeartMate III with HeartMate II®™ including a primary endpoint of survival free of device replacement and debilitating stroke. The first 294 randomized patients in the trial 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 superiority of pre-specified secondary endpoints. Outside of the U.S., Thoratec completed enrollment of the HeartMate III CE Mark study in late 2014 and continues to expect a commercial approval and launch in European markets during late 2015.

About Thoratec

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 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

Related Links

http://www.thoratec.com