Industry insiders consider transcatheter mitral valve replacement as the next big thing after transcatheter aortic valve replacement (TAVR), with a potentially significant market for TMVR. The CE Mark for Tendyne represents a win for Abbott against Edwards Lifesciences (NYSE:EW) and Medtronic (NYSE:MDT) — leaders in the TAVR space.
The CE Mark for the Tendyne system is for treating significant mitral regurgitation (MR) in people who require heart valve replacement but don’t have surgery or mitral repair as an option.
The Tendyne TMVI system is designed to replace the mitral valve in people in need of symptom relief and quality-of-life improvement without open surgery when transcatheter mitral repair is not possible. According to a news release, studies showed that 98.9% of Tendyne patients experienced MR elimination at discharge, which was sustained throughout one year.
Abbott Park, Ill.–based Abbott’s Tendyne system is capable of adapting to a range of patient anatomies, the company said. It is a self-expanding valve that is delivered through a small incision in the chest and sent up through the heart, where it is implanted in a beating heart to replace the native mitral valve. It is designed to be fully repositionable and retrievable during implantation.
“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,” senior VP of Abbott’s structural heart business Michael Dale said in the news release. “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.”
University Hospital Bonn, Germany professor of cardiac surgery Dr. Hendrik Treede said that the European approval for Tendyne offers the clinical community a new option for approaching a leaking mitral valve.
“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,” Treede added.
Abbott is already a leader in transcatheter mitral valve technology development, with its MitraClip device, a transcatheter heart valve repair device designed to treat mitral regurgitation. It secured its first FDA approval in 2013 and won FDA approval for its most advanced version, the MitraClip G4, in August 2019.
There is an ongoing legal battle over patents for the MitraClip technology between Abbott and Edwards Lifesciences (NYSE:EW). Edwards asked the U.S. Patent Trial and Review Board to review 25 claims that Evalve/Abbott hold on the MitraClip patent. Earlier this month, the board shot down Edwards’ attempt to invalidate the patents.
