Critical care, cardiology, policy  

Circulatory support system gains German approval for reimbursement

7 February 2006

Mass, USA. The governmental authority for healthcare charge reimbursement in Germany (InEK) has granted the highest approval level available for Abiomed's Impella Recover devices. The new German reimbursement standard will apply to the Impella Recove LP 2.5, 5.0, RD, and the LD, which are available in Europe under the CE Mark and are investigational in the United States.

The Company has also recently received product registration approval in France and is importingthe devices. Germany and France represent the largest circulatory assist markets in Europe.

German reimbursement is critical for healthcare market adoption of new technologies as it allows hospitals to provide advanced care to their patients in a cost effective manner. Hospitals in Germany are required to negotiate the reimbursement of advanced technologies, medical treatments, and patient related procedural expenses directly with the insurance companies. ABIOMED received a status 1 rating, the highest available, for the Impella technology to support these negotiations and future reimbursement with the German government authorities. Successful registration of Impella products in France provides a new opportunity for sales of ABIOMED's full Impella product line in the second largest market in Europe.

"We are focused globally on cost-effective solutions for acute heart failure and our products offer life saving options for the number one cause of death and the number one cost to global healthcare systems" said Michael R. Minogue, Chairman, CEO and President of Abiomed.

The Recover LP 2.5 is a minimally invasive ventricular unloading catheter, which is inserted percutaneously via the femoral artery into the left ventricle. Up to 2.5 litres 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. A large percentage of patients with acute myocardial infarction require a temporary mechanical support system in order to survive. The Recover LP 2.5 can be inserted quickly and provides efficient cardiovascular support. The Recover LP 2.5 can be implanted for up to 5 days.

The Recover LP 5.0 is a ventricular unloading catheter, which is placed via a femoral artery cut-down into the left ventricle. Once in place, up to 5 litres of blood per minute is pumped from the left ventricle into the ascending aorta — actively unloading the heart. The CE Marked Recover LP 5.0 has been used in Europe to support patients with post-cardiotomy failure to wean, post PCI, myocarditis, cardiogenic shock or as a bridge-to-next decision.

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