US-based Abiomed has received 510(k) clearance from the US FDA for its Impella percutaneous heart pump, which provides peak flows of approximately four litres of blood per minute.
The catheter-based Impella device is intended for partial circulatory support, using an extracorporeal bypass control unit for periods up to six hours, and to provide partial circulatory support during surgical procedures not requiring cardiopulmonary bypass.
Abiomed plans a controlled launch of the device with top heart hospitals in the US and expects to make it commercially available in across the country by the fourth quarter of fiscal 2013.
Washington University School of Medicine, St Louis, medical director Dr John Lasala said the Impella CP promises considerable cardiac power and quick insertion, ideal for patients that require more hemodynamic support.
“It is exciting for physicians to be able to provide this type of percutaneous support that represents approximately 80% of what a healthy heart can pump each minute,” Lasala said.
The new heart pump, which will be marketed in the US as Impella Cardiac Power (CP), has been commercially known as the Impella cVAD outside the US.
The increased flow of Impella CP is delivered on the same console platform, 9 French catheter, and has similar indications for use as the Impella 2.5.
The 510(k) clearance designates a limitation in the Impella CP instructions for use (IFU), according to Abiomed.
Abiomed chairman, president and chief executive officer Michael Minogue said; “The addition of the Impella CP to the growing Abiomed product portfolio further emphasizes the company’s commitment to innovation and our dedication to patients.”