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Data from a post-approval study supported an updated indication for patients “without the presence of profound shock, end organ failure or acute neurologic injury,” the agency said. Read More
Results from a clinical trial showed a 62 percent reduction in physician misses of aortic calcification and a 33 percent reduction in misses of dilated aortas, the company said. Read More
The FDA has approved updated labeling of Abiomed’s Impella RP system to better characterize the type of patients who may benefit most from using the heart pump. Read More