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Medtronic plc announced positive clinical data for its investigational Avalus pericardial aortic surgical valve, intended for the treatment of aortic valve disease. Presented at the 30th European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting for the first time, results from the PERIGON (Pericardial Surgical Aortic Valve Replacement) pivotal trial showed low rates of adverse valve-related events, high survival and improved hemodynamic performance at one year.
One of the largest, most comprehensive and modern data sets of surgical aortic valve replacement (SAVR) patients, the PERIGON pivotal trial is a single arm, non-randomized, prospective study of approximately 1,300 patients from 40 clinical sites across Europe, Canada, Japan and the United States. In the cohort presented at EACTS, outcomes of 270 patients were analyzed at the one-year endpoint.
The vast majority (91 percent) of patients were at low mortality risk for open heart surgery (STS<=4 percent), with the remaining 8 percent at intermediate risk (STS=4 to 8...