Abbott Makes Strong Statement in TMVR Space with SUMMIT

Abbott Laboratories has hit a substantial milestone in its plan to bring the Tendyne transcatheter mitral valve replacement (TMVR) system to the U.S. market. The Abbott Park, IL-based company said it has initiated SUMMIT, a pivotal clinical study of the TMVR system. Up to 1,010 patients will be enrolled in up to 80 sites in the pivotal trial. Abbott said the investigational Tendyne device is the first and only mitral valve replacement that can be repositioned and fully retrieved, allowing the surgeon to precisely place the device during implantation, which could improve patient outcomes. Tendyne is a tri-leaflet, bioprosthetic valve available in multiple sizes, and is stabilized by a pad and a tether mechanism that holds the pad in place where it's been implanted inside the native valve. The study will determine if treatment with the Tendyne TMVR system is safe and effective for patients suffering from severe mitral regurgitation. SUMMIT investigators will evaluate a composite endpoint of death, cardiovascular hospitalization, stroke or reoperation at one year. The first several patients in the trial were treated at Ascension's Via Christi Hospital St. Francis in Wichita, KS. and the West Virginia University Heart and Vascular Institute in Morgantown, WV. In an email, Abbott told MD+DI  enrollment in the SUMMIT study is anticipated to be completed within four years and the primary endpoint wi...
Source: MDDI - Category: Medical Devices Authors: Tags: Implants Cardiovascular Source Type: news