Thoratec Receives Conditional FDA Approval For HeartMate PHP Trial

Thoratec has won FDA conditional approval for an investigational device exemption clinical trial evaluating its HeartMate PHP acute catheter-based heart pump, the Pleasanton, Calif., devicemaker announced Tuesday. The company expects final FDA approval in the next few months, as well as CE Mark approval for the device during the same timeframe.

The SHIELD II study will enroll up to 425 patients undergoing a high-risk percutaneous coronary intervention across 60 sites, with the HeartMate PHP being tested against Abiomed’s Impella 2.5 in a 2:1 ratio. The company has set a primary endpoint of non-inferiority based on a composite of adverse events at 90-day follow-up, and expects to start enrolling patients during the third quarter of this year.

The HeartMate PHP generates an average blood flow of four to five liters per minute, following delivery through a percutaneous insertion, and is hemocompatible. — Jason Scott