Abbott has launched a clinical trial of its investigational Tendyne Transcatheter Mitral Valve Replacement (TMVR) device in the US to treat patients with mitral regurgitation (MR).
Designed for MR patients who need a minimally invasive replacement valve, Tendyne allows repositioning and complete retrieval to ensure precise placement during implantations.
This tri-leaflet, bioprosthetic valve eliminates the need for an open heart surgery. It comes in various sizes and conforms to a variety of anatomies, enabling easy use and better patient outcomes.
The pivotal SUMMIT trial will assess the safety and efficacy of treatment with the TMVR system in up to 1,010 severe MR patients at 80 sites across the US, European Union (EU) and Canada.
During the trial, the investigators will monitor patients for a composite endpoint of death, cardiovascular hospitalisation, stroke or reoperation at one year.
Abbott structural heart business vice-president Michael Dale said: “Transcatheter mitral valve replacement represents a new frontier in treating people whose valve does not close properly and who would benefit from a replacement valve instead of repair.
“Our scientists and engineers are building on our expertise to advance transcatheter mitral valve replacement with our Tendyne technology to provide a needed treatment option.”
Mitral regurgitation is a debilitating and life-threatening disorder, where the heart’s mitral valve does not close completely, leading to a backward flow of blood and leakage into the left atrium.
If left untreated, the disease can result in irregular heartbeats, stroke, heart failure and death.
Apart from the pivotal MR trial, the company is also planning for a feasibility study of the Tendyne device in patients with severe mitral annular calcification (MAC), a condition characterised by calcium accumulates on the left side of the heart.