United States Pivotal Trial Begins for Abbott Structural Heart's Tendyne TMVR Device
July 26, 2018—Abbott Structural Heart announced it has initiated the SUMMIT trial, a United States pivotal clinical study of the company's Tendyne transcatheter mitral valve replacement (TMVR) system for the treatment of mitral regurgitation (MR).
The SUMMIT study will enroll up to 1,010 patients at 80 sites in the United States, Europe, and Canada to evaluate the safety and efficacy of treatment with the Tendyne TMVR in patients with severe MR. Investigators will evaluate a composite endpoint of death, cardiovascular hospitalization, stroke, or reoperation at 1 year.
In addition to the United States pivotal trial, Abbott Structural Heart advised that it will initiate a separate feasibility study of the Tendyne system in patients with severe mitral annular calcification.
According to the company, the investigational Tendyne device can be repositioned and fully retrieved, allowing the interventionalist to precisely place the device during implantation, which could improve patient outcomes. The Tendyne device is a trileaflet, bioprosthetic valve in multiple sizes that is stabilized by a pad with a tether mechanism that holds the pad in place where it's been implanted inside the native valve.
The SUMMIT study's coprincipal investigators are Jason Rogers, MD, and Gorav Ailawadi, MD. Dr. Rogers is Professor and Director of Interventional Cardiology at the University of California at Davis Medical Center in Sacramento, California. Dr. Ailawadi is Professor of Surgery and Chief of Cardiac Surgery at the University of Virginia in Charlottesville, Virginia.
The first patients in the trial were treated at Ascension's Via Christi Hospital St. Francis in Wichita, Kansas and the West Virginia University Heart and Vascular Institute in Morgantown, West Virginia. Bassem M. Chehab, MD, Medical Director of Via Christi's structural heart program implanted the Tendyne valve in the first patient in the study.
In the company's announcement, Dr. Chehab stated, "The mitral valve is known for its complex anatomy and, as a result, managing MR can be challenging, especially in elderly or frail patients for whom there are limited to no treatment options. I'm encouraged by promising early results from the global study and excited about the potential for the Tendyne device to advance the field of TMVR in the United States by providing another option for MR patients needing a minimally invasive alternative."
Abbott Structural Heart recently announced that 30-day outcomes from the first 100 patients treated in a global study of the Tendyne TMVR system were presented at EuroPCR 2018, which was held May 22–25 in Paris, France. Results showed that, at 30 days, patients treated with Tendyne had a significant reduction in symptoms of MR and low mortality rates.