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Biotech / Medical : ABIOMED --an under valued small co.
ABMD 381.020.0%Jan 3 3:00 PM EDT

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To: Capevet who wrote ()6/11/1997 12:01:00 PM
From: Capevet   of 11
 
DANVERS, Mass., June 11 (Reuter) - Abiomed Inc <ABMD.O> said Wednesday the FDA had approved an amendment to its premarket approval application allowing expanded uses for the company's BVS-5000 bi-ventricular support system.

The BVS-5000, in use since 1993, is a cardiac assist device for temporary circulatory support of patients following heart surgery.

The company said the expanded approval allows the device to be used to treat all patients who are likely to recover cardiac function after the failing heart is permitted to rest under circulatory support.

Expanded uses include treatment of acute cardiac disorders such as viral myocarditis which often strikes young adults, the company said.

In May 1996, an earlier amendment approved by the FDA allowed additional indications such as treatment of failed transplant patients who require cardiac support following transplants, the company added.
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