Thoratec receives the European CE Mark approval to introduce its HeartMate PHP (Percutaneous Heart Pump). It is a hemodynamic support system during high-risk percutaneous coronary interventions.
The device is able to move up to five liters of blood per minute powered by a tiny motor spinning at about 20,000 RPMs. It is inserted percutaneously through the femoral artery using a 14 French sheath.
Once delivered into the aortic valve, it expands to 24 French, eventually delivering near-normal blood flow through the vessel.
The HeartMate PHP was designed to impart low shear stress to the blood flowing through the pump, helping to reduce the chance of clot formation and the potential for a stroke.
"PHP is an entirely new opportunity for Thoratec. Although the current catheter pump market outside the U.S. is relatively small, we look forward to gaining valuable clinical and commercial experience through a targeted European launch of HeartMate PHP in the coming months," said D. Keith Grossman, President and Chief Executive Officer.