PLEASANTON, Calif., June 27, 2014 /PRNewswire/ -- Thoratec Corporation (NASDAQ: THOR), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, said today that its CE Mark Clinical Trial for HeartMate III(TM) commenced with the first patient implanted with this new device.
"We are pleased to reach this significant clinical milestone with an important pipeline product," said Gary F. Burbach, President and Chief Executive Officer. "We are also excited about the potential for HeartMate III to advance heart failure therapy, improve clinical outcomes and enhance the patient experience," he added.
HeartMate III is a centrifugal-flow chronic left ventricular assist system. The fully magnetically levitated technology foundation of HeartMate III is designed to lower adverse event rates through improved hemocompatibility while enhancing ease of surgical placement through a compact size.
The Hannover Medical School in Hannover, Germany performed the first human implant of HeartMate III under the direction of surgeon Jan Schmitto, M.D., Ph.D. and Professor Axel Haverich M.D., chief of the Cardiothoracic, Transplantation and Vascular Surgery Department at the Hannover Medical School. "I am highly enthusiastic about the potential for HeartMate III based on its elegant implant technique and the promise of improved clinical outcomes," commented Dr. Schmitto. This implant marked the first patient enrolled in the HeartMate III CE Mark Clinical Trial, which will enroll up to 50 patients at nine sites in Europe, Australia, and Canada. The study includes a primary endpoint of six-month survival compared with estimated mortality based on the Seattle Heart Failure Model.
In addition to the first implant performed by Dr. Schmitto in Hannover, Germany, enrollment of the HeartMate III CE Mark Trial has also commenced at the Vienna Medical University in Vienna, Austria with an implant under the direction of Daniel Zimpfer M.D., Director of Mechanical Circulatory Support and Professor Gunther Laufer M.D., Head of the Department of Cardiac Surgery. "We are very pleased to participate in this important study that will help to advance the field of mechanical circulatory support with next generation LVAD technology from Thoratec," said Dr. Zimpfer.
Thoratec is a world leader in therapies to address advanced-stage heart failure. The company's products include the HeartMate II and HeartMate III 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 and distributes 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.
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 FDA or foreign regulatory authority 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