PLEASANTON, Calif., May 26, 2015 -- Thoratec Corporation (NASDAQ: THOR), a world leader in mechanical circulatory support therapies to save, support and restore failing hearts, announced that the FDA has granted conditional approval for a U.S. IDE clinical trial to investigate use of the HeartMate PHP acute catheter-based heart pump in patients undergoing a high-risk percutaneous coronary intervention. The SHIELD II (Supporting patients undergoing HIgh-risk PCI using a high-flow pErcutaneous Left ventricular support Device) U.S. clinical trial will randomize up to 425 patients at up to 60 sites against the Impella® 2.5 at a 2:1 ratio. Individual sites may immediately begin randomization after performing a series of up to three HeartMate PHP procedures for purposes of training and familiarity. The primary endpoint will measure non-inferiority based on a composite of adverse events at 90 days of follow-up. Final FDA approval is expected in the coming months pending resolution of certain routine technical questions.
HeartMate PHP is an acute cardiac assist device designed to disrupt the traditional relationship between size and flow in catheter-based support devices. The proprietary expandable catheter technology of HeartMate PHP is capable of generating average blood flow of four to five liters per minute following delivery through a true percutaneous insertion. The device has also been designed for hemocompatibility, with operating RPMs of 17,000-20,000.
"Swift FDA approval of our newly proposed U.S. trial design represents the latest step in our significant progress with the HeartMate PHP program as we rapidly move closer to delivering this innovative technology to market," said D. Keith Grossman, President and Chief Executive Officer. While conditional FDA approval allows for immediate start of the HeartMate PHP U.S. clinical trial, enrollment is expected to begin during the third quarter of 2015 following site selection and training.
Outside the U.S., Thoratec continues to expect CE Mark approval for HeartMate PHP during the third quarter. Additionally, clinical experience continues to advance internationally, with HeartMate PHP featured in a live high-risk PCI case presented at the recent EuroPCR conference in Paris. "The HeartMate PHP demonstrated ease of deployment with an ability to provide stable hemodynamic support during this complex cardiac case. This exciting new technology has the potential to provide improved clinical outcomes to a large population of patients in need of acute circulatory assistance," said Dr. Nicolas van Mieghem, the HeartMate PHP CE Mark trial investigator who performed the case at Erasmus Medical Center in Rotterdam, Netherlands for live transmission to EuroPCR attendees.
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. HeartMate PHP is a trademark of Thoratec Corporation. CentriMag and PediMag are registered trademarks of Thoratec LLC, and PediVAS is a registered trademark of Thoratec Switzerland GmbH.
Abiomed is a registered trademark of Abiomed, Inc. Impella is a registered trademark of Abiomed Europe 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.