The approval was granted based on data from the first 30 patients of the HeartMate PHP SHIELD I CE mark trial, which assessed the device in patients undergoing a high-risk percutaneous coronary intervention (PCI) procedure.
HeartMate PHP features an expandable catheter technology that can generate average blood flow of four to five liters per minute following delivery through a true percutaneous insertion.
Thorate has developed the device for hemocompatibility, with typical operating rpms of 17,000-20,000.
Thoratec president and CEO Keith Grossman said: "PHP is an entirely new opportunity for Thoratec. Although the current catheter pump market outside the US 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."
Recently, Thoratec obtained unconditional approval from the FDA for the device’s Shield II US IDE trial and patient enrollment will be started during the third quarter this year.
The firm’s products comprise HeartMate II and HeartMate 3 Left Ventricular Assist Systems (LVAS) and Thoratec ventricular assist device (VAD).
