News | June 14, 2012

Abiomed Receives Health Canada Approval for Impella cVAD

New percutaneous ventricular assist device provides higher level of hemodynamic support

June 14, 2012 — Abiomed Inc. said today it received Health Canada approval to market the Impella cVAD (ventricular assist device), a new percutaneous Impella heart pump that provides peak flow of approximately 4 liters of blood per minute.

The Impella cVAD1 is designed to provide temporary circulatory support via a minimally invasive, catheter-based pump that is inserted percutaneously, without the need for surgical intervention. The increased flow is delivered on the same console platform, 9 French catheter, and introducer as the Impella 2.5, which proivided 2.5 liters of flow.

"We are proud to announce the commercial Canadian availability of the new Impella cVAD device. This follows the April CE mark approval, where early European physician feedback has been quite positive," said Michael R. Minogue, chairman, president and CEO, Abiomed.

The Impella cVAD is not currently cleared for sale or use in the United States.

For more information: www.abiomed.com

 

Reference:

1. According to the labeling under Health Canada and the European Union, the Impella cVAD is intended for clinical use in cardiology and in cardiac surgery for up to five days for the following indications, as well as others: as a circulatory support system for patients with reduced left ventricular function, e.g., post-cardiotomy, low output syndrome, cardiogenic shock after acute myocardial infarction, or for myocardial protection after acute myocardial infarction; 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 ; as support during high risk percutaneous coronary intervention (PCI); post PCI.

 

Related Content

Medtronic Receives FDA Approval for Less-Invasive Heart Pump Implant Procedure
Technology | Ventricular Assist Devices (VAD) | July 17, 2018
Medtronic plc recently received U.S. Food and Drug Administration (FDA) approval for a less-invasive implant approach...
CorWave's Next-generation Neptune LVAD Receives Funding

Image courtesy of CorWave

News | Ventricular Assist Devices (VAD) | July 11, 2018
French-based CorWave announced that its CALYPSO program has received 14 million euros to develop CorWave Neptune, a new...
Abbott Recalls the HeartMate 3 Left Ventricular Assist System, LVAD
News | Ventricular Assist Devices (VAD) | May 23, 2018
Abbott has initiated a Class I recall of the HeartMate 3 Left Ventricular Assist System due to a malfunction in the...
FDA Approves Abiomed Impella CP With SmartAssist and Optical Sensor
Technology | Ventricular Assist Devices (VAD) | April 02, 2018
Abiomed Inc. announced that it received U.S. Food and Drug Administration (FDA) Pre-Market Approval (PMA) for its...
Reduced Device Clotting, Decreased Strokes Seen With HeartMate 3 at Two Years
News | Ventricular Assist Devices (VAD) | March 13, 2018
At two years of follow-up, severely ill patients with advanced heart failure who received a novel heart pump fully...
Medtronic HeartWare HVAD System Approved for Destination Therapy
Technology | Ventricular Assist Devices (VAD) | October 04, 2017
October 4, 2017 — Medtronic received U.S.
Abiomed Receives FDA PMA Approval for Impella RP for Right Heart Failure
Technology | Ventricular Assist Devices (VAD) | September 28, 2017
Abiomed Inc. recently received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for the Impella RP ...
Abbott Receives FDA Approval for HeartMate 3 Left Ventricular Assist System
Technology | Ventricular Assist Devices (VAD) | August 29, 2017
Abbott announced it has received U.S. Food and Drug Administration (FDA) approval for its Full MagLev HeartMate 3 Left...
Pre-PCI Impella 2.5 Insertion Improves Survival in Left Main Coronary Artery Heart Attacks
News | Ventricular Assist Devices (VAD) | June 30, 2017
Abiomed Inc. announced the recent publication of a peer-reviewed retrospective study on hemodynamic support with the...
Overlay Init