Thoratec Announces First HeartMate 3™ Implant in European Less Invasive Surgical Trial

Jul 06, 2015, 16:25 ET from Thoratec Corporation

PLEASANTON, Calif., July 6, 2015 /PRNewswire/ -- Thoratec Corporation (NASDAQ: THOR), a world leader in mechanical circulatory support therapies to save, support and restore failing hearts, announced the first ever HeartMate 3™ implant performed via mini-thoracotomy.  This implant begins a European study to evaluate outcomes and complications using less invasive surgical placement through hemi-sternotomy and left thoracotomy techniques.  The study will include ten cases performed at three European centers following one initial case to build experience at each center, and will measure the outcomes specified in the HeartMate 3 CE Mark trial after 30 days of follow-up.

HeartMate 3 is a centrifugal-flow chronic left ventricular assist system.  The fully magnetically levitated technology foundation of HeartMate 3 is designed to lower adverse event rates through improved hemocompatibility while enhancing ease of surgical placement through a compact size.  "This achievement marks the latest step in our progress with HeartMate 3, and will help build important clinical experience as we validate the surgical versatility of this exciting new technology," said D. Keith Grossman, President and Chief Executive Officer. 

The first less invasive surgery with HeartMate 3 was performed at the Institute for Clinical and Experimental Medicine (IKEM) in Prague, Czech Republic by Associate Professor Ivan Netuka, M.D. PhD, Deputy Head at IKEM and Jan Schmitto M.D. PhD, MBA, Director of the Mechanical Circulatory Support and Cardiac Transplantation Program at the Hannover Medical School in Hannover, Germany.  "The pump design ensured elegant placement in a petite 70-year-old female with body surface area of 1.65 m2, and the patient has been discharged from the hospital in a normal post-operative manner.  This demonstrates that HeartMate 3 can accommodate choice in surgical placement.  We look forward to confirming an encouraging initial experience in this ongoing trial," commented Dr. Netuka.  "The ease of implant, combined with potential for improved clinical outcomes with HeartMate 3, provide for a very attractive next generation device capable of treating a wide range of patients," added Dr. Schmitto.

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," "views," "expects," "should," "hopes," "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, the growth of existing markets for our products, customer and physician acceptance of Thoratec products, the effects of international and FDA regulatory requirements, and 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. 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



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