Abiomed receives FDA 510(k) Clearance for new, HIGHER FLOW IMPELLA percutaneous heart pump, with peak flows of 4l/min
DANVERS, Mass. — September 10, 2012 -- Abiomed, Inc.
“The Impella CP promises a substantial amount of cardiac power, can be inserted quickly, and is ideal for patients that require more hemodynamic support,” said John Lasala MD, medical director of Washington University School of Medicine in St. Louis. “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.”
This 510(k) clearance designates that the Impella CP has the same indications for use(1) as the Impella 2.5 and includes a limitation in the Impella CP instructions for use (IFU).(2) In April 2012, Abiomed received CE Marking approval to market the Impella cVAD in the European Union.(3) Abiomed plans to have a controlled launch with top heart hospitals in the United States, with full U.S. commercial availability of the Impella CP expected by the fourth quarter of fiscal 2013.
Abiomed has three FDA studies (PROTECT I, RECOVER I, PROTECT II) that are now published on Impella, and there are also over 150 peer-reviewed publications including real world usage data from the Europe and U.S. Impella registries. Additionally, Impella has been utilized to support over 10,000 U.S. patients, has been incorporated into the medical guidelines and has recently been approved for a dedicated CPT code for physician payment.
1. Indication: 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.”
2. For Impella CP only: “The safety and effectiveness of this device has not been established for use in providing partial or full support of the blood circulation for periods of greater than six hours, or for providing prophylactic hemodynamic support, for example, in patients with stable hemodynamics during percutaneous interventional procedures of high risk coronary artery lesions and/or anatomy.”
3. Upon CE Marking approval, Abiomed partnered with nine key opinion leaders and institutions in the European Union to conduct a limited market release. This successful market evaluation validated the performance and ease of use of the new Impella pump, introducer, and Automated Impella Controller (AIC) operating software.