Abiomed Receives Health Canada Approval for Impella cVAD
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
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.