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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