Abiomed receives conditional approval from FDA for circulatory support system
Shares of Abiomed, Inc. (Nasdaq: ABMD) are advancing out of the gate this morning after the seller of medical devices to assist or replace the pumping function of the failing heart announced it has received conditional approval from the U.S. Food and Drug Administration to begin a clinical trial for its Impella 2.5 Circulatory Support System.
Approval is conditional upon the Abiomed’s submission of additional information to the FDA over the next 45 days.
The company’s study will determine the safety and effectiveness of the Impella 2.5 compared with optimal medical management with an Intra-Aortic Balloon Pump during "high-risk" angioplasty procedures.
Shares of Abiomed rose $0.04, or 0.33%, to $12 just after the bell.
