| DANVERS,
Mass. (September 10, 2004) – ABIOMED, Inc. (NASDAQ:
ABMD) today announced that the Company has placed its first European
orders for the AB5000 Circulatory Support System at Herzzentrum Nordrhein-Westfalen
in Bad Oeynhausen, Germany, Azienda Ospedaliera Niguarda Ca'Granda
in Milan, Italy, and University Hospital Lund in Lund, Sweden. The
sales follow the Company's announcement on its most recent quarterly
investor call that it has launched a plan to expand business internationally.
The AB5000 provides temporary support for one or both sides of the
natural heart in circumstances where the heart has failed, giving
the patient's heart the opportunity to rest and potentially recover
-- and giving surgeons the therapeutic flexibility necessary to determine
the best endpoint for treatment.
"We are very pleased that three of the most accomplished clinical
and research centers for cardiac medicine in Europe have chosen
to be early adopters of ABIOMED's new life saving heart assist and
recovery system," said Michael R. Minogue, CEO and President
of ABIOMED. "We are committed to making these systems available
globally and offering patients worldwide the possibility of recovering
after a serious cardiac event, and returning home with their natural
hearts, untethered by permanent devices."
"By making this system available to allow patients hearts
to rest and potentially recover following a cardiac event, we will
be giving them a greatly improved chance of survival," said
Prof. Dr. Rainer Korfer at Herzzentrum Nordrhein-Westfalen. "Because
the system is transportable, patients can go on support at their
local hospitals and be transferred to a more advanced cardiac center
if necessary. This network program allows for rapid intervention,
which saves lives. We believe that having this kind of life saving
system available to our patients is essential to our high standard
of care."
The AB5000 Circulatory Support System consists of two principal
components. The AB5000 Ventricle is a disposable blood pump capable
of supporting the left, right, or both ventricles of the heart and
is designed to provide improved patient mobility, comfort and ease
of use. The AB5000 Console is an advanced, software-driven system
that drives the blood pumps and can be used either in the hospital
or for transport of patients between hospitals.
Key Facts on the AB5000 Circulatory Support System:
- The AB5000 is ABIOMED's newest product offering, approved by
the FDA in 2003. It is based on technology developed for the AbioCor
Implantable Replacement Heart.
- The AB5000 Console is an advanced system with upgradeable software.
It offers the flexibility of driving either the BVS 5000 blood
pump or the AB5000 ventricle to support the left, right or both
ventricles of the heart. In ongoing bench testing, the AB5000
Circulatory Support System has maintained performance exceeding
six months of operation.
- Unlike other ventricular assist systems that can require multiple
drivers for a single patient, patients on the AB5000 require only
a single console – regardless of condition.
- The AB5000 is designed to allow patients to leave their hospital
rooms and walk within the hospital and on hospital grounds. Multiple
studies have shown that patient ambulation, or walking, greatly
assists the recovery process. The ease of use and transport capability
of the AB5000 System makes it an important option for both regional
and local cardiac centers.
- Patients can be put on the AB5000 or the BVS 5000 System –
ABIOMED's other temporary circulatory support offering -- at their
local hospital and then be transported to more advanced cardiac
centers if necessary. This network program has been shown to greatly
improve chances of survival for patients.
Based in Danvers, Massachusetts, ABIOMED, Inc. (pronounced “AB’-EE-O-MED”)
is a leading developer, manufacturer and marketer of medical products
designed to assist or replace the pumping function of the failing
heart. ABIOMED currently manufactures and sells the AB5000™
Circulatory Support System and the BVS® 5000 Biventricular Support
System for the temporary support of all patients with failing but
potentially recoverable hearts. The Company’s AbioCor®
Implantable Replacement Heart is the subject of an initial clinical
trial being conducted under an Investigational Device Exemption
from the United States Food and Drug Administration. The AbioCor
has not been approved for commercial distribution, and is not available
for use or sale outside of the initial clinical trial.
###
Media Contact:
Andrea tenBroek
Communications Specialist
(978) 646-1419
mediarelations@abiomed.com
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