Thoratec (NSDQ:THOR) today said it won an investigation device exemption from the FDA for a clinical trial comparing its HeartMate PHP catheter-based heart pump with Abiomed‘s (NSDQ:ABMD) Impella 2.5 device.
Pleasanton, Calif.-based Thoratec said the Shield II trial is slated to enroll up to 425 patients at up to 60 sites, randomized against the Impella device at a 2:1 ratio. The trial’s primary endpoint is non-inferiority based on a composite of adverse events at 90 days.
The company said it expects final FDA approval for the HeartMate PHP "in the coming months pending resolution of certain routine technical questions."
Abiomed won pre-market approval from the FDA for its flagship Impella 2.5 in March, after the FDA’s Circulatory Devices panel recommended in late 2012 that percutaneous cardiac assist devices be subject to the FDA’s most stringent PMA protocol. The pump had been allowed on the U.S. market via the FDA’s less-stringent 510(k) clearance protocol.
Thoratec said its special sauce is a proprietary expandable catheter "capable of generating average blood flow of 4 to 5 liters per minute following delivery through a true percutaneous insertion."
"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," president & CE Keith Grossman said in prepared remarks.
Thoratec said it expects to begin enrolling patients in Shield II during the 3rd quarter. CE Mark approval in the European Union is also expected during the 3rd quarter, the company said.