PLEASANTON, Calif., Sept. 27, 2015 /PRNewswire/ -- Thoratec Corporation (NASDAQ: THOR), a world leader in mechanical circulatory support therapies to save, support and restore failing hearts, today announced results from the HeartMate 3™ CE Mark trial. HeartMate 3 met the primary endpoint, a comparison of six month survival to a performance goal derived from the INTERMACS registry, with six month survival of 92% surpassing the performance goal and representing the highest six month survival reported in a LVAD CE Mark clinical trial. Results of the HeartMate 3 CE Mark trial were presented today during the 19th Annual Scientific Meeting of the Heart Failure Society of America (HFSA 2015) in Washington, DC.
"The CE Mark trial data represents a very positive initial experience with HeartMate 3, including high survival rates, material improvement in functional status, and very low adverse event rates highlighted by zero pump thrombosis events," said Dr. Ivan Netuka, presenter of the HeartMate 3 CE Mark study data at HFSA and Deputy Head at the Institute for Clinical and Experimental Medicine (IKEM) in Prague, Czech Republic. "HeartMate 3 is a very promising LVAD technology based on the advancement in clinical outcomes demonstrated in this trial," added Dr. Netuka.
Survival with HeartMate 3 at six months was 92% compared with the HeartMate II® INTERMACS derived performance goal of 88%, achieving the primary endpoint and representing exceptional six month survival. Overall functional status improved significantly with HeartMate 3 support as measured by changes in the six minute walk distance and NYHA classification. At six months, patients experienced median improvement of 231 meters in the six minute walk test, and 83% of patients improved to NYHA Class I or II status, representing statistically significant improvements compared with baseline status.
Overall adverse event rates with HeartMate 3 were either lower than or consistent with expectations for severely ill complex patients requiring LVAD support. There were no instances of pump thrombosis, hemolysis, or device malfunction during the six month follow-up period. Gastrointestinal bleeding, another common adverse event with LVAD therapy, occurred in only 8% of patients with HeartMate 3 and was notably below event rates in previously published data from prior LVAD clinical trials. Stroke occurred in 12% of patients, including 8% with ischemic and 4% with hemorrhagic events. Half of these events (3 of 6), were determined to be procedural related and may not represent risk related to the device. Two of the three non-procedural related stroke events were Modified Rankin Scale (MRS) 1 in patients that remain on HeartMate 3 support. Despite inclusion of these potentially non-device related and MRS 1 events, reported stroke rates in the CE Mark trial were still consistent with expected rates based on prior LVAD trial experience.
"We are extraordinarily pleased with the performance of HeartMate 3 in this initial experience, and it is gratifying to see the promise of our Full Maglev technology demonstrated clearly in these clinical results," said D. Keith Grossman, President & Chief Executive Officer. "We look forward to working with clinicians, both in ongoing clinical trials and in the imminent commercial launch in Europe, to extend the benefits of this exciting new technology to the underserved and growing population of advanced heart failure patients," he added.
HeartMate 3 is a centrifugal-flow chronic left ventricular assist system utilizing Full MagLev™, 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 HeartMate 3 CE Mark trial is a prospective, multi-center, non-randomized study designed to examine the first human experience with HeartMate 3. The study enrolled 50 patients at ten hospitals in six countries outside of the U.S. between June and November 2014. Enrollment included both bridge-to-transplant and destination therapy patients in NYHA Class IIIb or IV heart failure, and the primary endpoint comparing six month survival to a performance goal derived from the INTERMACS registry has been met. Patient follow-up will continue during the first two years of ongoing support, while enrollment in the HeartMate 3 U.S. IDE trial remains ongoing. Thoratec expects to receive CE Mark approval for HeartMate 3 during the fourth quarter of 2015.
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," "expects," "should," "could," "will," 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, 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.
SOURCE Thoratec Corporation