Healthcare Industry News: IVAD
News Release - September 4, 2015
Thoratec Announces Start Of Shield II(TM) U.S. Clinical TrialPLEASANTON, Calif., Sept. 4, 2015 -- (Healthcare Sales & Marketing Network) -- Thoratec Corporation (THOR), a world leader in mechanical circulatory support therapies to save, support and restore failing hearts, announced today that it has begun enrollment in the SHIELD II U.S. clinical trial examining the HeartMate PHP™ in patients undergoing a high-risk PCI (percutaneous coronary intervention) procedure. The first case was performed by interventional cardiologist Dr. Robert Pyo at Montefiore Medical Center. "SHIELD II is off to an encouraging start as the HeartMate PHP was easily deployed and provided consistent hemodynamic stability during the first case," said Dr. Ulrich Jorde, Vice Chief of Cardiology and Section Head of Heart Failure, Cardiac Transplantation, and Mechanical Circulatory Support at Montefiore Medical Center, Albert Einstein College of Medicine, New York.
"SHIELD II marks the beginning of our clinical experience with PHP in the large and important U.S. market," said D. Keith Grossman, President and Chief Executive Officer. "We look forward to the significant clinical data expected from SHIELD II and the ultimate commercialization of PHP in the U.S.," he added.
HeartMate PHP is an acute cardiac assist device designed to uncouple 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 been designed for hemocompatibility, with typical operating speeds between 17,000-20,000 RPMs.
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 one 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. The study will be led by three National Principal Investigators: Dr. Ulrich Jorde of Montefiore Medical Center, Dr. David Kandzari of Piedmont Heart Institute, and Dr. Navin Kapur of Tufts University Medical Center. "We expect that data from SHIELD II will further demonstrate the clinical value of PHP, and could not only advance the rapidly emerging market for percutaneous hemodynamic support in complex coronary revascularization but also support further study in expanded indications," said Dr. Kandzari, Director of Interventional Cardiology and Chief Scientific Officer at Piedmont.
Thoratec is a world leader in therapies to address advanced-stage heart failure. The company's products include the HeartMate II® and HeartMate 3™ 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®, PediMag®/PediVAS®, and HeartMate PHP™ product lines. HeartMate 3 and HeartMate PHP are investigational devices and are limited by US law to investigational use. 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 3, HeartMate PHP, and IVAD 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," "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, and 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.
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