PLEASANTON, Calif., Oct. 6, 2015 /PRNewswire/ -- Thoratec Corporation (NASDAQ: THOR), a world leader in mechanical circulatory support therapies to save, support and restore failing hearts, highlighted recent clinical presentations from the European Association for Cardio-Thoracic Surgery (EACTS) annual meeting in Amsterdam, including three presentations that build upon the positive initial data from the HeartMate 3 CE Mark trial that was recently presented at the Heart Failure Society of America conference.
During EACTS, Dr. Assel Medresova of the National Research Center for Cardiac Surgery in Astana, Kazakhstan reviewed data from the largest single center experience currently available with HeartMate 3. This data set, which was first presented at the recent 23rd Annual Meeting of the International Society for Rotary Blood Pumps (ISRBP) by Dr. Yuri Pya, included 30-day follow-up on 23 consecutive HeartMate 3 patients implanted after receiving local regulatory approval. Reported 30-day outcomes were highlighted by 96% survival and low overall adverse event rates, including zero incidents of stroke or device thrombosis.
Additionally, EACTS featured a video presentation of a HeartMate 3 implant performed via a less invasive surgical placement. This case represents one of the six implants completed to date in the ongoing study at three leading European centers including the Deutsches Herzzentrum Berlin, the Medizinische Hochschule Hannover, and the Institute for Clinical and Experimental Medicine (IKEM) in Prague to evaluate HeartMate 3 with a thoracotomy technique. “Our successful early experience in this study demonstrates the potential versatility of HeartMate 3, and we look forward to further exploration of how this new technology can meaningfully improve the treatment of advanced heart failure patients,” said Dr. Ivan Netuka, Deputy Head at IKEM and lead surgeon in the less invasive case presented at EACTS.
The EACTS meeting also included a presentation of 30-day outcome data from the HeartMate 3 CE Mark clinical trial. This presentation from Dr. Daniel Zimpfer, Assistant Professor of Surgery at the Medical University of Vienna, focused on short-term outcomes during the CE Mark trial, including an impressive 30-day survival of 98%. This result represents exceptionally low operative mortality risk despite 42% of patients requiring additional surgical procedures performed during the pump implantation. In addition, this presentation highlighted some of the innovative design features of HeartMate 3 that help facilitate the surgical procedure, including the unique mechanical apical cuff which enables surgeons to quickly lock the pump in place without the need for additional tools.
“Collectively, these presentations continue a successful beginning of what will ultimately become a vast body of clinical evidence supporting HeartMate 3,” said D. Keith Grossman, President and Chief Executive Officer. “We are very pleased to see this incremental data further validate the great potential of HeartMate 3 that was first evident in the CE Mark trial results, and believe these impressive outcomes will greatly benefit a large and underserved patient population suffering from advanced heart failure,” he added.
HeartMate PHP was also featured at EACTS with the broadcast of a successful live case performed at the Erasmus Medical Center in Rotterdam. This high-risk percutaneous intervention (PCI) case represented the 50th and final patient in the full cohort of the SHIELD I CE Mark trial to evaluate HeartMate PHP in high-risk PCI cases. HeartMate PHP received CE Mark approval in July based on data from the first 30 patients enrolled in SHIELD I, and enrollment in the SHIELD II U.S. IDE study is ongoing.
About Thoratec
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,” “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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SOURCE Thoratec Corporation
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