FDA okays Abiomed's new access mode for BVS 5000 system:
This article was originally published in Clinica
Executive Summary
The US FDA has approved Abiomed's PMA supplement to use an alternative method of surgical access with its BVS 5000 biventricular cardiac support system. The approval allows doctors to use the apex of the heart's left ventricle as the site of access to blood. Many doctors have indicated a preference for the new approach, says the Danvers, Massachusetts company. They now have the flexibility of supporting the failing heart by accessing blood via the left atrium or the left ventricle.
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