Thoratec Corporation has announced that HeartMate PHP (Percutaneous Heart Pump) received CE Mark approval, permitting sale in the European Union and other international countries. 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 RPMs of 17,000-20,000.
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.
“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 Chief Executive Officer, Thoratec.
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. IDE study. The SHIELD II U.S. IDE trial recently received unconditional approval from the FDA and is still expected to begin enrollment during the third quarter.