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Being Presented at a Satellite Symposium during the 85th Annual Meeting
of the American Association for Thoracic Surgery
DANVERS, Mass. (April 7, 2005) - ABIOMED, Inc.
(Nasdaq: ABMD) a manufacturer of products for circulatory care and
support, today announced that Karim Benali, M.D. MS (VP Product
Development) will be presenting a summary of data from more than
2,400 patients that suffered cardiogenic shock (CS) after acute
heart failure. The presentation will be delivered at a satellite
symposium during the 85th Annual Meeting of the American Association
for Thoracic Surgery being held in San Francisco, CA. The presentation
is scheduled for Sunday, April 10, 2005 at 7:00 p.m. PDT.
Dr. Benali will share the clinical trends from ABIOMED's volunteer
database registry of 2,474 entries, which includes 270 AMI-CS patients.
Acute Myocardial Infarction (AMI) is estimated to occur in approximately
865,000 patients annually in the United States. Of these patients,
between 7-10% suffer cardiogenic shock (CS), which typically occurs
a few hours after AMI and is the leading cause of death in patients
hospitalized for AMI (Hochman et al. NEJM 1999; 341:9). The current
standard of care for AMI-CS patients includes emergency revascularization
in a cath lab supported by inotropic drugs and an intra-aortic balloon
pump to stabilize the patient. The in- hospital mortality rate for
patients receiving this standard therapy is 47 percent (Sanborn
et al. JACC 2000; 36:1123). Current data suggests that early use
of ABIOMED technology such as BVS 5000 and AB5000 ventricular assist
devices (VAD) are likely to have a greater impact on improving survival
of these patient populations. These devices alleviate some of the
pressure and reduce the workload of the beating heart, allowing
the cardiac muscle time to recover when possible.
One hundred sixty open heart and transplant centers have reported
AMI-CS VAD results to ABIOMED's volunteer registry. Of these, 21
centers reported results using the AB5000 support system, which
was introduced in April 2004. The cumulative data of AMI-CS patients
supported with the AB5000 have shown survival rates approaching
50 percent among the high-risk mortality population that has received
the current standard of care. Sixty percent of these survivors recovered
their native heart function and were discharged home with their
own heart. Recovery for an AMI-CS patient has been shown to require
an average Length Of Support (LOS) of about 30 days where survival
requires an average LOS of 32 days. The recovery LOS is 3 to 4 times
that of previous results with twice the rate of recovery. Dr. Benali
will discuss the advantage of early VAD assist and the potential
benefit of bi-ventricular support in this patient population.
"Early diagnosis and intervention is essential in helping
patients recover from AMI-CS, thus avoiding the challenges that
can be encountered with other solutions such as heart transplant
or permanent device dependency. As cardiologists are involved early
in the treatment of AMI patients, it becomes increasingly important
to involve and inform them about the benefit of VAD technology in
supporting AMI-CS. Patient referral for early VAD support becomes
crucial when all other standard of care solutions have been exhausted.
The current clinical data provides us with an even greater body
of evidence demonstrating the value of early intervention that we
can share with this important group of critical care providers,"
commented Michael R. Minogue, Chief Executive Officer and President
of ABIOMED.
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.
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Media Contact:
Communications Specialist
(978) 646-1419
mediarelations@abiomed.com
Investor Relations Contact:
Edward E. Berger, Ph.D.
Vice President for Policy, Reimbursement and External Relations
(978) 646-1411
ir@abiomed.com
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