Edwards Lifesciences in the US has secured the European CE-Mark for its Cardioband Tricuspid Valve Reconstruction System designed to treat tricuspid heart valve disease.
Performed through transfemoral route, this transcatheter therapy minimises tricuspid regurgitation through annular reduction.
The system facilitates accurate positioning to the specific anatomy of a patient, along with real-time adjustment and simultaneous confirmation of results.
Edwards Lifesciences transcatheter mitral and tricuspid therapies corporate vice-president Bernard Zovighian said: “We are very pleased to be developing the most comprehensive product portfolio to address both mitral and tricuspid valve disease and to demonstrate continued progress on this robust pipeline of innovative transcatheter therapies for patients in need.
“We are committed to building a significant body of clinical evidence, including the collection of real-world data, on this important new therapy for patients who have few or no other treatment options.”
The European approval is based on the clinical results obtained from TRI-REPAIR CE Mark study, in which the Cardioband System demonstrated potential as a treatment option for tricuspid regurgitation.
University Hospital Bonn Cardiology department chief Georg Nickenig said: “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.
“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.”
Edwards Lifesciences purchased the Cardioband System from Valtech Cardio in January last year. The CE-Mark triggers a pre-specified milestone payment of about $50m to former Valtech Cardio investors.