Thoratec Announces the First Human Use of HeartMate PHP™
PLEASANTON, Calif., March 18, 2013 /PRNewswire/ -- Thoratec Corporation (THOR), a world leader in device-based mechanical circulatory support (MCS) therapies to save, support, and restore failing hearts, announced today that it has successfully completed the first human use of HeartMate PHP (Percutaneous Heart Pump). The first PHP patient was supported for over 60 minutes during a high-risk percutaneous coronary intervention (HR PCI). The patient was hemodynamically stable during the procedure, which involved three-vessel intervention on a patient with an ejection fraction less than 30 percent. Two additional patients were treated as part of this first-in-man series. The procedures were performed by Adrian Ebner, M.D. at Sanatorio Italiano in Asuncion, Paraguay. Dr. Ebner is the Chief of the Cardiovascular Department at Sanatorio Italiano.
The HeartMate PHP system is a catheter-based heart pump designed to provide hemodynamic left ventricular support. Upon insertion into the femoral artery via an integrated 12F introducer sheath, the PHP catheter is advanced into the left ventricle where the distal end of the catheter expands to 24F, allowing for enhanced blood flow with low levels of hemolysis. Thoratec has designed the PHP system to facilitate rapid insertion using an intuitive control console and to provide 4-5 liters per minute of mean flow for support durations up to several days.
"We are delighted to have participated in the first human experience with HeartMate PHP," said Dr. Ebner. "The PHP technology represents a potential breakthrough in MCS therapy, providing the support required for hemodynamically unstable patients. Without PHP in place during this high-risk procedure, we might not have been able to achieve complete revascularization."
"I am pleased with the level of support the PHP system provided in this milestone case," said Michael Ennen, Vice President and General Manager of Thoratec's Interventional Business. "In just three years, our team has taken PHP from concept to clinical utilization, and we look forward to advancing our evaluation of this next-generation percutaneous support system."
Thoratec intends to pursue clinical investigations on the use of HeartMate PHP to support patients undergoing high-risk percutaneous interventions as well as those in cardiogenic shock, a population with persistently high mortality rates. The company is planning a continuation of the pilot study during the second quarter and anticipates initiating a CE Mark study in the second half of 2013. The PHP system complements Thoratec's surgical-based MCS pump platforms such as HeartMate II and CentriMag, providing a complete continuum of circulatory support products.
"This First-in-Human experience with HeartMate PHP demonstrates Thoratec's commitment to our mission of providing physicians with superior MCS solutions, for both chronic and acute support needs, in order to dramatically improve patient outcomes," said Gary Burbach, Thoratec's President and CEO.
Thoratec is the world leader in mechanical circulatory support with the broadest product portfolio to treat the full range of clinical needs for patients suffering from advanced heart failure. The company's products include the HeartMate LVAS and Thoratec VAD, with more than 20,000 devices implanted in patients suffering from heart failure. Thoratec also manufactures and markets the CentriMag and PediMag / PediVAS product lines. Thoratec is headquartered in Pleasanton, California. For more information, visit www.thoratec.com.
Thoratec, the Thoratec logo, HeartMate and HeartMate II are registered trademarks of Thoratec Corporation and 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.
Many of 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," "plans," "projects," "hopes," "could," "will," "intends," 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 development of new products and new markets, the growth of existing markets for our products, customer and physician acceptance of Thoratec products, the effects of FDA regulatory requirements, and the effects of competition. Forward-looking statements contained in this press release should be considered in light 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