Thoratec Announces Completion Of Enrollment In The HeartMate III™ CE Mark Trial

PLEASANTON, Calif., Dec. 1, 2014 /PRNewswire/ -- Thoratec Corporation THOR, a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, today announced completion of enrollment in the HeartMate III CE Mark trial.  This trial enrolled a total of 50 patients at ten sites across Europe, Canada, and Australia.

"We are very pleased with the rapid completion of enrollment in the HeartMate III CE Mark study, marking a significant clinical milestone in the mechanical circulatory support industry," said D. Keith Grossman, President and Chief Executive Officer.  "Our swift enrollment pace demonstrates the growing enthusiasm for HeartMate III across the clinical community and keeps us well on schedule to meet targeted timelines for approval of this exciting new technology," 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.  The CE Mark trial will evaluate patient survival with a six-month follow up period, which will be reached in May 2015.  Thoratec continues to expect regulatory submission of CE Mark data next year, with an approval and commercial launch in 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.

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SOURCE Thoratec Corporation