New higher-flow version catheter-based heart pump

[Pyankov Vasily]

September 10, 2012—Abiomed, Inc. (Danvers, MA) announced that it has received 510(k) clearance from the US Food and Drug Administration for a new higher-flow version of its percutaneous, catheter-based Impella heart pump. The new Impella device provides peak blood flows of approximately 4 L/min and is delivered on the same console platform, 9-F catheter, and introducer as the Impella 2.5 device.

http://www.medgadget.com/2012/09/impell ... n-u-s.html

INDICATIONS FOR USE IN THE UNITED STATES

The Impella® 2.5 Circulatory Support System 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.
The Impella® 2.5 Circulatory Support System also provides pressure measurements which are useful in determining intravascular pressure.

INTENDED USE IN THE EUROPEAN UNION AND CANADA

The Impella® 2.5 (intracardiac pump for supporting the left ventricle) is intended for clinical use in cardiology and in cardiac surgery for up to 5 days for the following indications, as well as others:
• The Impella® 2.5 is a circulatory support system for patients with reduced left ventricular function, eg, postcardiotomy, low output syndrome, cardiogenic shock after acute myocardial infarction, or for myocardial protection after acute myocardial infarction
• The Impella® 2.5 may also be used as a cardiovascular support system during coronary bypass surgery on the beating heart, particularly in patients with limited preoperative ejection fraction with a high risk of postoperative low output syndrome
• Support during high risk percutaneous coronary intervention (PCI)
• Post PCI

[Igor Bulatov]

DOJ Investigating Abiomed For Improper Marketing Of Impella Circulatory Support System http://www.forbes.com/sites/larryhusten ... rt-system/