Abiomed receives conditional FDA approval for clinical trial
Conditional approval has been granted by the U.S. Food and Drug Administration (FDA) for medical device provider Abiomed to begin a clinical trial in the United States for the Impella 2.5 circulatory support system.
Abiomed said it received pre-approval because it submitted the clinical results of the safety pilot clinical trial and is conditional upon the Danvers, Mass.-based company’s submission of additional information to the FDA over the next 45 days.
The study will determine the safety and effectiveness of the Impella 2.5 compared to medical management with an intra-aortic balloon pump during angioplasty procedures, and will include patients with triple vessel disease with low ejection fraction, according to Abiomed.
Abiomed said it received pre-approval because it submitted the clinical results of the safety pilot clinical trial and is conditional upon the Danvers, Mass.-based company’s submission of additional information to the FDA over the next 45 days.
The study will determine the safety and effectiveness of the Impella 2.5 compared to medical management with an intra-aortic balloon pump during angioplasty procedures, and will include patients with triple vessel disease with low ejection fraction, according to Abiomed.