In Brief: Abiomed
This article was originally published in The Gray Sheet
Executive Summary
Abiomed: Receives premarket approval application supplement to broaden the indications for its BVS-5000 biventricular support system to include "all patients with recoverable heart function," the firm states. In 1993 the device was approved for "temporary circulatory support of patients who fail to wean from cardiopulmonary bypass following heart surgery," the firm says. The recently approved indications cover "patients suffering from acute cardiac disorders such as, but not limited to, viral myocarditis"...