Thoratec, a world leader in mechanical circulatory support therapies to save, support and restore failing hearts, announced that the FDA has granted conditional approval for a US IDE clinical trial to investigate use of the HeartMate PHP acute catheter-based heart pump in patients undergoing a high-risk percutaneous coronary intervention.
The SHIELD II (Supporting patients undergoing HIgh-risk PCI using a high-flow pErcutaneous Left ventricular support Device) U.S. clinical trial will randomize up to 425 patients at up to 60 sites against the Impella 2.5 at a 2:1 ratio.
Individual sites may immediately begin randomization after performing a series of up to three HeartMate PHP procedures for purposes of training and familiarity. The primary endpoint will measure non-inferiority based on a composite of adverse events at 90 days of follow-up. Final FDA approval is expected in the coming months pending resolution of certain routine technical questions.
HeartMate PHP is an acute cardiac assist device designed to disrupt 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 also been designed for hemocompatibility, with operating RPMs of 17,000-20,000.
"Swift FDA approval of our newly proposed U.S. trial design represents the latest step in our significant progress with the HeartMate PHP program as we rapidly move closer to delivering this innovative technology to market," said D. Keith Grossman, President and Chief Executive Officer.
While conditional FDA approval allows for immediate start of the HeartMate PHP U.S. clinical trial, enrollment is expected to begin during the third quarter of 2015 following site selection and training.
Outside the US, Thoratec continues to expect CE Mark approval for HeartMate PHP during the third quarter. Additionally, clinical experience continues to advance internationally, with HeartMate PHP featured in a live high-risk PCI case presented at the recent EuroPCR conference in Paris.