HeartMate PHP (Percutaneous Heart Pump) receives CE Mark approval- Thoratec

Thoratec Corporation announced that HeartMate PHP (Percutaneous Heart Pump) received CE Mark approval, permitting sale in the European Union and other international countries. 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 PCI (percutaneous coronary intervention) procedure. Data from all 50 patients enrolled in this 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 technology of HeartMate PHP is capable of generating average blood flow of four to five litres per minute following delivery through a true percutaneous insertion. The device has been designed for haemocompatibility, with typical operating RPMs of 17,000-20,000.