| Heart
Failure Patient at University Hospital in Lund, Sweden, is due to
return home
DANVERS, Mass. (October 13, 2004) – ABIOMED,
Inc. (NASDAQ: ABMD) today announced that the first European patient
to have his heart supported by the AB5000 Circulatory Support System
has recovered from acute fulminant myocarditis. The AB5000 provides
temporary support for one or both sides of the native 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.
Mr. Christer Söderqvist, a patient of Dr. Bansi Koul at University
Hospital Lund in Sweden, suffered from a cardiac arrest while he
was being treated for cardiogenic shock and was considered to have
close to 100% risk of mortality. A policeman, Mr. Christer Söderqvist
had been previously healthy when he began to show symptoms of acute
heart failure. Over two days his situation deteriorated, culminating
in a severe shock requiring CPR and stabilization with the heart
lung machine. He was immediately placed on the BVS5000 Circulatory
Support System to support both sides of his heart, which helped
improve his stability and blood flow. After 4 days, he was switched
to ABIOMED's AB5000 Ventricles to prepare him for a longer duration
of support and to allow him improved mobility.
"Converting from the BVS 5000 to the AB5000 was done in about
fifteen minutes in the critical care unit, without re-opening the
patient's chest," commented Dr. Koul. He also noted that the
patient, who during the treatment developed heparin-induced thrombocytopenia,
was managed with an alternative regimen of anti-coagulation without
any clots forming.
After 20 days of total support, it was determined that Mr. Christer
Söderqvist's native heart had fully recovered and was once
again able to sustain his circulation. The AB5000 was successfully
explanted and the patient is due to be discharged from the hospital.
"By first stabilizing Mr. Christer Söderqvist on the BVS
5000 and then converting to the AB5000, the clinical team had adequate
time to assess the patient and determine the best course for treatment,"
commented Dr. Koul. "In this case, receiving bi-ventricular
support on the AB5000 allowed the patient's heart to recover. In
other cases, if it appears that the patient's heart is too damaged
to recover we will be able to work with the patient and family to
consider other options including heart transplant and, in the future,
the AbioCor implantable artificial heart."
"We are delighted that Mr. Christer Söderqvist, our first
AB5000 patient in Europe, continues to do well," said Michael
R. Minogue, CEO and President of ABIOMED. "It is always particularly
good news when a patient on our device not only survives a life
threatening cardiac event, but also returns home with his natural
heart recovered. Being able to switch from the BVS5000 to the AB5000
without re-opening the chest also helps with recovery, as there
is a greatly reduced possibility of infection or bleeding. We are
continuing to work to make our life saving systems available to
surgeons worldwide so that more patients like Mr. Christer Söderqvist
can be saved."
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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