Valtech has received German Neue Untersuchungs und Behandlungsmethoden (NUB) Status 1 approval for the Cardioband mitral reconstruction system (translated to German as: Endovaskuläre Mitralklappenanuloplastik mit Anuloplastie-Band).
This product is its flagship device for addressing mitral regurgitation in heart failure patients. NUB approval for the procedure grants reimbursement for Cardioband therapy in 70 leading hospitals in Germany.
Amir Gross, founder and chief executive officer of Valtech, says, “The Cardioband system is designed to offer a safe and effective catheter-based alternative to open heart surgery.” It combines a reconstruction implant, similar to those used in traditional surgical annuloplasty devices, with a transfemoral, transseptal delivery system. Sutureless connection of the implant to the mitral annulus should be achieved using specially designed anchors. Reshaping of the mitral annulus to eliminate mitral regurgitation is done under physiological conditions and echocardiographic guidance for optimal results.
Cardioband received CE mark approval after clinical trial results demonstrated the device is a safe and efficacious intervention option for patients with functional mitral regurgitation.