Edwards gains CE mark for first transcatheter tricuspid treatment

Edwards Lifesciences has received CE mark approval for its Cardioband Tricuspid Valve Reconstruction System, making it the first commercially available transcatheter therapy to treat tricuspid valve heart disease.

Delivered via a transfemoral approach, the system is designed to reduce tricuspid regurgitation through annular reduction. According to an Edwards press release, it uses the same design and implant technique as the Cardioband Mitral System.

"Although open-heart surgical valve repair is practiced today, it has not been performed frequently for those suffering from tricuspid regurgitation, despite evidence of increased mortality in these patients," Georg Nickenig, a cardiologist at University Hospital in Bonn, Germany, said in the release. "Now with the European approval of the Cardioband Tricuspid System as the first transcatheter tricuspid therapy, patients can have access to a minimally invasive treatment designed to reduce tricuspid regurgitation and improve their symptoms and quality of life."

Data on the system will be presented at EuroPCR 2018, an interventional cardiovascular medicine conference taking place May 22-25 in Paris.