Medical devices and health care firm Abbott has obtained the CE Mark approval of its Tendyne Transcatheter Mitral Valve Implantation (TMVI) system for use in the European Union.
The Tendyne system is indicated for treating mitral regurgitation (MR) in patients, who need heart valve replacement and offers a safe solution for MR patients who are not candidates for open-heart surgery or transcatheter mitral valve repair.
Abbott structural heart business senior vice president Michael Dale said: “The launch of the Tendyne device builds upon our history of developing groundbreaking therapies that offer new treatment options for people with serious structural heart conditions who have limited treatment options.
“The availability of Tendyne as a treatment option in Europe provides physicians with an additional tool that has been shown to completely correct MR in very ill patients, and it adds to Abbott’s portfolio of life-changing and life-saving treatments.”
Tendyne TMVI system is a self-expanding valve
MR is one of the common, debilitating, progressive and life-threatening heart diseases that affect heart valves, characterised by the incomplete opening of heart’s mitral valve, resulting in backward flow of blood into the left atrium of the heart.
The Tendyne system is said to offer an alternative minimally invasive treatment option for patients at risk of open-heart surgery or with severely damaged mitral valve, facilitating the replacement of leaky valve.
Abbott said that the Tendyne valve is a first-of-its-kind therapy to replace the mitral valve in patients in need of symptom relief and quality-of-life improvement without open surgery and when transcatheter mitral repair is not possible.
In addition, clinical trials conducted for the system across the world have demonstrated superior procedural safety and MR elimination in patients during discharge.
The Tendyne TMVI system is a self-expanding valve delivered through a small incision in the chest, where it is implanted in a beating heart, replacing the person’s native mitral valve.
The cardiac implant is designed to adapt to different patient anatomies. It is an investigational device in the US.
Clinique Pasteur interventional cardiologist Nicolas Dumonteil said: “For the first time outside of clinical trial settings, heart teams now have a minimally invasive valve replacement therapy that is backed by an excellent safety profile and designed to help physicians reposition the device as needed for improved patient outcomes.”
