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Valtech Cardio receives CE mark for mitral reconstruction device
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Valtech Cardio Ltd. announced that it has received European CE mark approval for an implantable mitral reconstruction device, according to a company press release.
The Cardioband device includes a transfemoral, transseptal delivery system allowing surgical-like mitral valve repair and adjustment of a beating heart in real time, according to the release. The system does not interfere with mitral valve leaflets or chordae and also does not eliminate the possibility of other future treatment options should they be needed.
CE mark approval follows results from a multicenter feasibility trial, in which patients treated with Cardioband exhibited significant improvements to mitral regurgitation and annular size. Among treated patients, 82% exhibited significant improvements to quality of life and 6-minute walk test results, and were classified as NYHA class I to II at 6 months. At 12 months, 94% exhibited sustained mitral regurgitation of 2+ or lower.
“The future of functional mitral regurgitation treatment lies in the repair-and-replace paradigm,” Francesco Maisano, MD, chairman and professor of cardiovascular surgery at the University Hospital of Zurich, said in the release. “Mitral regurgitation repair with Cardioband can be the first-line therapy for severe mitral regurgitation patients. Additionally, early-stage repair can support ventricular reverse remodeling while keeping the options open for the patient, supporting the technology’s use at earlier stages.”
Disclosure: Maisano reports consulting for Abbott, Edwards Lifesciences, Medtronic, St. Jude Medical and Valtech Cardio.