The data shows that Edwards' bioprosthetic surgical aortic valves featuring the company's novel RESILIA tissue platform continued to demonstrate favorable safety and hemodynamic performance through a median of four years follow-up, with no events of structural valve deterioration (SVD). The COMMENCE study enrolled 694 patients, 144 (21 percent) of which were under the age of 60 when they had surgical valve replacement. The data were presented at the American Association for Thoracic Surgery's (AATS) 99th annual meeting.
10/9/18: The prospective, single-arm, multi-center study is expected to enroll approximately 1,000 patients and includes a bicuspid registry. The study has a composite endpoint of all-cause death and/or all stroke at 1 year reports the company.
6/28/18: CMS announced that it has opened the NCA to reconsider the National Coverage Determination (NCD) released in 2012 for TAVR. This development was clearly expected and the analysis will examine the extensive body of evidence regarding the clinical, economic and quality of life benefits of TAVR.
June 13, 2017
Enrollment of first European subject in transcatheter tricuspid repair study was announced today. The SCOUT II Study using the Trialign System has commenced at leading medical centers across Europe.
Mitralign Inc., an innovative developer of transcatheter...
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