Valtech Cardio announced that it 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), 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.
"Reimbursement in Germany represents yet another milestone for Valtech in expanding therapeutic options globally for patients experiencing mitral regurgitation," said Amir Gross, Founder and CEO of Valtech.
"The Cardioband system is designed to offer a safe and effective catheter-based alternative to open heart surgery. Valtech is committed to developing a portfolio of catheter-based technologies to address the many complexities inherent in heart valve disease."
The Cardioband System 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 is achieved using specially designed anchors. Reshaping of the mitral annulus to eliminate mitral regurgitation (MR) 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 (FMR).
Valtech Cardio, founded in 2005, is a privately held company specializing in the development of devices for mitral and tricuspid valve repair and replacement.
Valtech has full in-house development, manufacturing and clinical research capabilities, and over 150 patents and patent applications.