Mini heart pump company Abiomed, Inc. has appeared on our pages on many occasions as its Impella® device treads the path towards approval and adoption. Now the company has announced it has received 510(k) clearance from the U.S. FDA for the increased flow version of its percutaneous, catheter-based device, providing peak flows of approximately four litres of blood per minute. The increased flow is delivered on the same console platform, 9 French catheter, and introducer as the Impella 2.5 which was approved in 2008. The new heart pump will be marketed as the Impella CP™ (Cardiac Power) within the United States and has been commercially known outside the U.S. as the Impella cVAD™.
Impella’s story is a good one, Abiomed now boasting use in over 10,000 U.S patients since FDA approved the 2.5 version back in 2008. Three FDA studies (PROTECT I, RECOVER I, PROTECT II) 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.
Impella cVAD, now to be known as CP in U.S, gained CE Mark approval to market the Impella cVAD in the EU in April of this year, as covered here. The company then partnered with nine key opinion leaders and institutions in the EU 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.
According to the newly announced FDA approval, like its sister Impella 2.5 product, 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.”
Unlike the 2.5 however, the Impella CP indications do not extend to provision of prophylactic haemodynamic support, for example, in patients with stable haemodynamics during percutaneous interventional procedures of high risk coronary artery lesions and/or anatomy.”
“The clinical community has been anxiously anticipating the arrival of this new Impella pump. 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 M.D., 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.”
“We are very pleased to announce the availability of the new Impella CP and we expect this to be a significant tool in helping more patients,” said Michael R. Minogue, Chairman, President and Chief Executive Officer, Abiomed. “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.”
Abiomed plans to have a controlled launch with top heart hospitals in the United States, with full commercial availability of the Impella CP expected by the fourth quarter of fiscal 2013.
Source: Abiomed, Inc., Globe Newswire