A multinational medical device manufacturer selected a New Jersey regional health network with roots of operation in the community back to 1890, as a trial site location for a surgical procedure that replaces a diseased aortic valve with an engineered valve. The trial site, Engelwood Health positions its hospital as a national leader in transcatheter aortic valve replacement (TAVR) to treat aortic stenosis (AS). Medtronic, the medical device maker and sponsor of the clinical trial, included the regional health network and hospital in the global EXPAND II Pivotal Trial. This is the first randomized clinical study evaluating the self-expanding, supra-annular Evolut™ TAVR platform in patients with moderate, symptomatic AS, a population outside of the current guidelines and indications for TAVR. Consequently, Englewood Health will enroll eligible patients in the new clinical trial investigating the expanded use of TAVR for treating patients with less severe aortic valve disease.
Now a trial site for the EXPAND II Pivotal Trial, involving.
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