DANVERS, Mass.--(BUSINESS WIRE)--Abiomed, Inc. (NASDAQ: ABMD) formally announced the results of its Impella® 2.5 PROTECT I safety trial for the first time at the Cardiovascular Research Foundation’s (CRF) annual Transcatheter Cardiovascular Therapeutics (TCT) Scientific Symposium and main sessions.
PROTECT I is the first prospective multi-center, FDA-approved trial for prophylactic, or preventative, use of a device during high-risk percutaneous coronary intervention (PCI) procedures. The 20 patient pilot study with the Impella 2.5 met all primary and secondary endpoints and showed very low adverse event rates in a very sick patient population. The results demonstrated no incidents of: aortic valve damage, aortic or mitral dysfunction, sepsis, stroke, thromboembolic events, vascular complications, insertion-site infection, device malfunction, device-related bleeding, limb ischemia, or clinical issues with hemolysis.
