Heart pumps: Abiomed gets FDA win for Impella CP
Medical device company Abiomed touts 510(k) clearance for its "higher flow" Impella CP heart pump.
The Danvers, Mass.-based medical device company said it landed 510(k) clearance from the FDA for the percutaneous, catheter-based heart pump, which it says can provide peak flows of 4 liters per minute, about 80% of what a healthy heart can pump.
The Impella CP is intended for "partial circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours. It is also intended to be used to provide partial circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass," according to a press release.