Thoratec Corp., a manufacturer mechanical circulatory support therapies, received CE mark for its HeartMate PHP (percutaneous heart pump).
Approval was based on data from the first 30 patients enrolled in the HeartMate PHP SHIELD I CE Mark Trial examining use of PHP to support patients undergoing a high-risk percutaneous coronary intervention procedure. Data from all 50 patients enrolled in this study will be presented later this year.
HeartMate PHP is an acute cardiac assist device designed to uncouple the traditional relationship between size and flow in catheter-based support devices. The proprietary expandable catheter technology of HeartMate PHP is capable of generating average blood flow of four to five liters per minute following delivery through a true percutaneous insertion. The device has been designed for hemocompatibility, with typical operating revolutions of 17,000-20,000 per minute.
"The SHIELD I clinical experience demonstrated both the performance and ease of use of HeartMate PHP, which was able to safely maintain or improve the hemodynamic profile of severely ill patients undergoing complex revascularizations," said Dariusz Dudek, M.D., SHIELD I principal investigator and physician in chief, Department of Cardiology and Cardiovascular Interventions at the University Hospital in Krakow, Poland.
"PHP is an entirely new opportunity for Thoratec. Although the current catheter pump market outside the U.S. is relatively small, we look forward to gaining valuable clinical and commercial experience through a targeted European launch of HeartMate PHP in the coming months," said D. Keith Grossman, president and CEO.
The HeartMate PHP European launch will include a measured rollout to targeted countries, staged through the balance of 2015 and 2016. Previously issued company guidance for 2015 financial results included the expected impact of revenue and costs associated with HeartMate PHP and the European launch, with internal resources principally focused on the HeartMate PHP U.S. investigation device exemption (IDE) study. The SHIELD II U.S. IDE trial recently received unconditional approval from the U.S. Food and Drug Administration and is still expected to begin enrollment during the third quarter.
Pleasanton, Calif.-based Thoratec’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 U.S. law to investigational use.