Thoratec Announces Start Of The HeartMate PHP? CE Mark Trial - Applied Clinical Trials


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Thoratec Announces Start Of The HeartMate PHP? CE Mark Trial

Thoratec Announces Start Of The HeartMate PHP™ CE Mark Trial

PR Newswire

PLEASANTON, Calif., Aug. 6, 2014 /PRNewswire/ -- Thoratec Corporation (NASDAQ: THOR), a world leader in mechanical circulatory support therapies to save, support and restore failing hearts, announced today that its CE Mark Clinical Trial for HeartMate PHPTM (Percutaneous Heart Pump) has commenced.

"We are excited to begin the CE Mark Clinical Trial for HeartMate PHP and look forward to successful execution of this important clinical study," said Gary F. Burbach, President and Chief Executive Officer.  "The HeartMate PHP addresses a significant clinical need for acute mechanical circulatory support and represents a new area of future growth for Thoratec," he added.

HeartMate PHP is a percutaneous device designed to deliver short-term support for patients needing acute cardiac assistance.  Through a proprietary expandable catheter technology, HeartMate PHP seeks to deliver improvements in device size, performance and clinical outcomes compared with currently available acute support technologies. 

A portion of the initial cases in the HeartMate PHP CE Mark trial were performed by Juan F. Granada M.D., Assistant Professor of Medicine at Columbia University in New York and Executive Director and Chief Innovation Officer at the CRF Skirball Center for Innovation.  Dr. Granada performed these cases at the Instituto del Corazón in Bucaramanga, Colombia and commented, "HeartMate PHP offers clinicians a new and effective alternative to address the need for short-term acute cardiac support," adding "the HeartMate PHP performance and ease of deployment are important advancements ideal for usage in this high-risk patient cohort that requires rapid and predictable hemodynamic stabilization."  Additional cases in the CE Mark trial were performed by Adrian Ebner M.D., Chief of the Cardiovascular Department at Sanatorio Italiano in Asuncion, Paraguay, where the first human cases using PHP were also successfully completed in 2013.

The HeartMate PHP CE Mark trial will enroll up to 50 patients at sites in Europe and South America.  The study will focus on use during high-risk percutaneous coronary interventions (high-risk PCI) and includes a primary endpoint of procedural success and avoidance of major adverse events for 30 days.  Dariusz Dudek M.D., Physician in Chief, Department of Cardiology and Cardiovascular Interventions at the University Hospital in Krakow, Poland, and principal investigator of the HeartMate PHP CE Mark Trial commented, "On behalf of all the investigators, I wish to congratulate the teams in South America on the initiation of the clinical study.  We look forward to treating patients in Europe with HeartMate PHP in the near future."

Thoratec is a world leader in therapies to address advanced-stage heart failure.  The company's products include the HeartMate II® 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 the CentriMag® and PediMag®/PediVAS® product lines. Thoratec is headquartered in Pleasanton, California. For more information, visit the company's website at

Thoratec, the Thoratec logo, HeartMate II are registered trademarks of Thoratec Corporation and HeartMate PHP, is a trademark 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," "plans," "projects," "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 development of new products, including development and clinical trial timing , 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, the effects of healthcare reimbursement and coverage policies, 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


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As it creates a plan to implement the US biosimilar pathway, should FDA:
Borrow heavily from EMA's pathway program?
Borrow lightly from EMA's pathway program?
Create entirely its own pathway program?
Borrow heavily from EMA's pathway program?
Borrow lightly from EMA's pathway program?
Create entirely its own pathway program?
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