Healthcare Industry News: IVAD
News Release - July 13, 2015
Thoratec Receives CE Mark Approval For HeartMate PHP(TM)PLEASANTON, Calif., July 13, 2015 -- (Healthcare Sales & Marketing Network) -- Thoratec Corporation (THOR), a world leader in mechanical circulatory support therapies to save, support and restore failing hearts, announced that HeartMate PHP (Percutaneous Heart Pump) received CE Mark approval, permitting sale in the European Union and other international countries. Approval was based on data from the first 30 patients enrolled in the HeartMate PHP SHIELD I CE Mark Trial examining use of PHP to support patients undergoing a high-risk PCI (percutaneous coronary intervention) procedure. Data from all 50 patients enrolled in this study will be presented later in 2015.
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 RPMs of 17,000-20,000. "The SHIELD I clinical experience demonstrated both the performance and ease of use of HeartMate PHP, which was able to safely maintain or improve the hemodynamic profile of severely ill patients undergoing complex revascularizations," said Dariusz Dudek, M.D., the SHIELD I principal investigator and Physician in Chief, Department of Cardiology and Cardiovascular Interventions at the University Hospital in Krakow, Poland.
"PHP is an entirely new opportunity for Thoratec. Although the current catheter pump market outside the U.S. is relatively small, we look forward to gaining valuable clinical and commercial experience through a targeted European launch of HeartMate PHP in the coming months," said D. Keith Grossman, President and Chief Executive Officer.
The HeartMate PHP European launch will include a measured rollout to targeted countries, staged through the balance of 2015 and 2016. Previously issued company guidance for 2015 financial results included the expected impact of revenue and costs associated with HeartMate PHP and the European launch, with internal resources principally focused on the HeartMate PHP U.S. IDE study. The SHIELD II U.S. IDE trial recently received unconditional approval from the FDA and is still expected to begin enrollment during the third quarter.
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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