Thoratec Snags CE Mark Approval for HeartMate PHP
Thoratec has won CE Mark certification for its HeartMate percutaneous heart pump, the Pleasanton, Calif., devicemaker said Monday.
Approval was based on data from a U.S. clinical trial evaluating the system for high-risk percutaneous coronary intervention procedures, the company says. It will make the study data available later this year.
The device features a catheter that can generate an average blood flow of four to five liters per minute following administration through percutaneous insertion, the devicemaker claims.
The company will conduct a staged launch across different countries through 2015 and into 2016, with another trial to begin enrollment the third quarter of this year. — Jason Scott