Abiomed Announces Canadian Regulatory Approvals Of Impella Circulatory Support Technologies
Danvers, MA - Abiomed, Inc. recently announced that the Company's Impella 2.5 and Impella 5.0 circulatory support technologies have been approved for use in Canada by Health Canada's Therapeutic Products Programme (TPP). In addition, the Company also announced that the first patients in Canada have received treatment with the Impella 2.5 technology at the Peter Munk Cardiac Centre at Toronto General Hospital.
"We are proud to be the first hospital in Canada to use this exciting new catheter-based circulatory support technology for heart failure patients. We expect the Impella devices to be key treatment options for clinicians in our cath lab and surgical suites," said Vladimir Dzavik, BSc, MD, FRCPC, Director, Cardiac Cath Lab and Interventional Cardiology at the Peter Munk Cardiac Centre, Toronto General Hospital University Health Network.
The Impella 2.5 is a ventricular assist catheter, which is inserted percutaneously in the catheterization laboratory (cath lab) via the femoral artery into the left ventricle. Up to 2.5 liters of blood per minute are delivered by the pump from the left ventricle into the ascending aorta, providing the heart with active support in critical situations. The Impella 2.5 can be inserted quickly and provides cardiovascular support for a high risk patient population while having their percutaneous coronary intervention (PCI), such as a stent or balloon angioplasty. It can also be used to provide additional blood flow to patients with low cardiac output, such as post-cardiotomy, or to protect the muscle of the heart following a heart attack. The device is currently available in Europe under the CE Mark. Abiomed recently announced that it has completed enrollment for the pilot study of the Impella 2.5 in the United States.
"Abiomed is focused on expanding the worldwide access to our heart recovery products through regulatory approval progress and we are pleased with this Canadian approval of our Impella platform. We look forward to working with Canadian cardiologists and surgeons to improve clinical outcomes for patients," said Michael R. Minogue, Chairman, CEO and President of Abiomed.
Abiomed's Impella 5.0 technology consists of catheters that can be introduced percutaneously through a cut-down or surgically. These pumps can achieve flows of up to 5.0 liters per minute, and actively unload the ventricle, reducing myocardial workload and oxygen consumption while increasing cardiac output and coronary and end-organ perfusion. The Impella 5.0 support systems are intended to be used for up to seven days as left ventricular cardiac assist devices. These technologies are currently available in Europe under the CE Mark and are in pilot studies in the United States under an Investigational Device Exemption (IDE).
Impella products are investigational devices limited by Federal Law solely to investigational use in the United States and are not currently available for sale in the United States.
SOURCE: Abiomed