Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its Cardioband transcatheter tricuspid valve reconstruction system, touting it as the first commercially cleared transcath therapy for treating tricuspid heart valve disease.
The Cardioband tricuspid system is designed to be delivered through a transfemoral approach and is intended to reduce tricuspid regurgitation through annular reduction, the Irvine, Calif.-baed company said. The system features the same design and implant technique as the company’s 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. 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,” Dr. Georg Nickenig of Bonn, Germany’s University Hospital said in a press release.
Edwards Lifesciences touted that the transcatheter solution allows for accurate positioning that takes into account patient-specific anatomy, and allows for real-time adjustment with the ability to confirm results of the placement.
“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. The clinical results of the Tri-Repair CE Mark study with the Cardioband tricuspid system demonstrate the promise of this treatment option for those with tricuspid regurgitation. 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,” transcath mitral and tricuspid therapies corporate VP Bernard Zovighian said in a prepared statement.
The clearance of the device was a pre-specified milestone in the deal, and as such prompted the distribution of cash and stock worth approximately $50 million to former Valtech investors, Edwards said.