Thursday, June 14, 2012

Abiomed, Inc. (ABMD) Receives Approval for Impella cVAD Device from Canada

Abiomed is a leading supplier of medical devices that provide breakthrough circulatory support. The company’s products are designed to enable the heart to rest by improving blood flow and/or performing the actual pumping of the heart.

The company reported today that it has received Health Canada (Canadian government department responsible for public health) approval to market its innovative Impella cVAD device in Canada. This device is a new percutaneous Impella heart pump that provides peak flow of approximately 4 liters of blood per minute. The Impella cVAD is designed to provide temporary circulatory support via a minimally invasive, catheter-based pump that is inserted percutaneously without the need for a major surgical procedure.

According to what Abiomed disclosed to Canadian and European authorities about the pump, it is intended solely to support the left ventricle of the heart. The company also said that it is intended for clinical use in cardiology and cardiac surgery for up to 5 days in patients with various symptoms, including reduced left ventricle function, low output syndrome, cardiogenic shock after a heart attack, and as a support for patients’ hearts during coronary bypass and other heart surgeries.

The approval of the Impella cVAD device in Canada is another success for Abiomed. It follows European approval of the device in April. Early feedback from European physicians who have used it has been extremely positive so far. To date, the FDA has not cleared the device for use in the US.

For additional information about Abiomed and its growing portfolio of hemodynamic support products, please visit the company’s website at www.abiomed.com

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