logo
Share SHARE
FONT-SIZE Plus   Neg

Abiomed Obtains FDA 510(k) Clearance For New Impella Percutaneous Heart Pump

Abiomed Inc. (ABMD), a provider of breakthrough heart support technologies, announced it has received 510(k) clearance from the U.S. Food and Drug Administration or FDA for a new percutaneous, catheter-based Impella device providing peak flows of approximately four liters of blood per minute.
The company stated that the increased flow is delivered on the same console platform, 9 French catheter, and introducer as the Impella 2.5. This 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.

This 510(k) clearance designated that the Impella CP has the same indications for use as the Impella 2.5 and includes a limitation in the Impella CP instructions for use or IFU, the company said.

In April 2012, Abiomed received CE Marking approval to market the Impella cVAD in the European Union.

Abiomed said it 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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
They say there's plenty of fish in the sea, but very few of them are as wealthy as these tycoons. May be they have been so busy building their empires they never had the time to stick with a perfect partner to build their family. This list of the richest singles is assorted — from a 34 year-old... Anthony Levandowski, the head of Uber's self-driving division, is stepping away from his role as Uber continues a legal battle with Waymo, Levandowski's former employer. Levandowski, who founded startup Otto, became head of Uber's Advanced Technologies Group or ATG after Otto was acquired by Uber in August 2016. Southwest Airlines Co. has decided to end the practice of overbooking flights, the airline's CEO Gary Kelly said Thursday. The airline's plan to end overbooking could be implemented from May 8, according to a Southwest spokeswoman.
comments powered by Disqus
Follow RTT