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Pleasanton-based Thoratec Corporation has received approval to use the CE Mark on its HeartMate PHP acute cardiac assist device.
The CE marking is the manufacturer’s declaration that the product meets the requirements of the applicable European Community directives.
The approval was based on data from the first 30 patients enrolled in the HeartMate CE Mark trial examination. Data from all 50 patients enrolled in the study will be presented later in 2015.
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 is capable of generating average blood flow of four to five liters per minute following delivery through a true percutaneous insertion.
“PHP is an entirely new opportunity for Thoratec,” said D. Keith Grossman, president and Chief Executive Officer of 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 in the coming months.”
The HeartMate PHP European launch will include a measured rollout to targeted countries, staged through the balance of 2015 and 2016.
Thoratec maintains its global headquarters at 6035 Stoneridge Drive. For more information, visit the company’s website at http://www.thoratec.com/