Resources for Food and Drug Administration (FDA)
Abiomed gets FDA OK to test new circulatory support system
boston.bizjournals.com Abiomed Inc. has received conditional approval from the U.S. Food and Drug Administration to begin a clinical trial in the United States for the Impella(R) 2.5 Circulatory Support System.
The study will determine the safety and effectiveness of the Impella 2.5 during high-risk angioplasty procedure, as compared to the optimal medical management with an Intra-Aortic Balloon Pump.The study will take place at 150 hospitals.
The FDA approval is the This approval is the result of the submission of the clinical results of the safety pilot clinical trial and is conditional upon the company's submission of additional information to the FDA over the next 45 days.
View the Resource
Share or bookmarklet this web page at:
|
RSS Feeds
