The governmental authority for 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 Abiomed's Impella Recover LP 2.5, Impella Recover 5.0, Impella Recover RD and Impella Recover LD, which are all available in Europe. The company also announced that it has recently received product registration approval in France and has now commenced shipment of Impella technologies to customers there. Germany and France represent the largest circulatory assist markets in Europe.
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 2.5L 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, and can be implanted for up to five 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 5L of blood per minute is pumped from the left ventricle into the ascending aorta - actively unloading the heart. The Recover LP 5.0 has been used in European centres to support patients with post-cardiotomy failure to wean, post PCI, myocarditis, cardiogenic shock or as a bridge-to-next decision.
Abiomed's Impella Recover devices also include the Recover RD, the smallest right ventricular unloading catheter available, and the Recover LD, the smallest left ventricular unloading catheter. The Impella Recover RD is implantable and can deliver up to 6.0L of blood per minute from the right atrium via the outlet graft to the pulmonary artery. The Recover LD is surgically implanted via the aorta into the left ventricle and delivers up to 5.0L of blood per minute into the ascending aorta. These devices can be used in combination to provide temporary bi-ventricular support in an effort to recover the natural function of a patient's heart.
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