FDA Grants Thoratec Approval for IDE Trial of HeartMate PHP

Thoratec Corp. was granted conditional approval by the U.S. Food and Drug Administration (FDA) for an investigational device exemption clinical trial to investigate use of the HeartMate PHP acute catheter-based heart pump in patients undergoing a high-risk percutaneous coronary intervention (PCI).

The trial will randomize up to 425 patients at up to 60 sites against the Impella 2.5, which is made by Danvers, Mass.-based Abiomed Inc., 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,” according to the company.

HeartMate PHP is an acute cardiac assist device designed to disrupt the traditional relationship between size and flow in catheter-based support devices. The device’s expandable catheter technology is capable of generating average blood flow of four to five liters per minute following delivery through a true percutaneous insertion, company officials said. The device also has been designed for hemocompatibility, with operating revolutions per minute 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 CEO.

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 United States, Thoratec officials expect CE mark approval for HeartMate PHP during the third quarter this year.

More clinical data was reported about the HeartMade PHP during the recent EuroPCR conference in Paris, France.

“The HeartMate PHP demonstrated ease of deployment with an ability to provide stable hemodynamic support during this complex cardiac case. This exciting new technology has the potential to provide improved clinical outcomes to a large population of patients in need of acute circulatory assistance,” said Nicolas van Mieghem, M.D., the HeartMate PHP CE mark trial investigator who performed the case at Erasmus Medical Center in Rotterdam, the Netherlands for live transmission to EuroPCR attendees.

Pleasanton, Calif.-based Thoratec makes technology to treat advanced-stage heart failure.