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Home » Thoratec Snags CE Mark Approval for HeartMate PHP
Thoratec Snags CE Mark Approval for HeartMate PHP
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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
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