OUR MISSION
Our mission is to develop solutions for mitral valve interventions that are faster, easier to use, and less invasive without compromising clinical efficacy.
Utilization of new and less invasive catheter-based methods allows treatments to be extended to patients who currently cannot be helped due to advanced age and/or concomitant diseases.
ABOUT MEDTENTIA
Medtentia is a cardiovascular device company developing transformative solutions for mitral valve repair based on its proprietary helix annuloplasty ring technology.
CathHELIX® – Novel Transcatheter Therapy for Mitral Valve Regurgitation
FACTS AND FIGURES
In the last decade, morbidity due to heart valve disease increased by more than 60 %. For people over 75, the increase was over 160 %, such that more than 10 % of this patient group are suffering from clinically relevant mitral valve disease.
The majority of mitral valve disease patients are not able to undergo treatments involving open heart surgery with cardiopulmonary bypass. CathHELIX® provides a new treatment option. This catheter-based mitral valve repair system has the potential to enable safer, faster, and considerably less traumatic cardiac interventions for mitral regurgitation patients worldwide, without compromising clinical efficacy.
One common sign of mitral valve disease is mitral valve leakage. However, primary mitral valve failure represents only a small proportion of patients suffering from mitral insufficiency (MI). The overwhelming majority suffer from functional mitral regurgitation (FMR).
FMR affects both the valve apparatus and the left ventricle. A treatment option is therefore vitally needed that not only prevents regurgitation, but is also able to stop (or even revert) the ventricular remodeling process.
PROCEDURE
We have developed CathHELIX®, a transcatheter mitral valve repair device, which has the potential to significantly reduce mitral regurgitation as well as inducing reverse ventricular remodeling.
The implantation procedure for the ring is primarily transesophageal echocardiography (TEE)-guided. The vascular approach is via the femoral vein.
The first step of the intervention is temporary contraction (shortening) of the coronary sinus (CS) using an anchoring effusion balloon catheter. The tension shortens the length of the CS and thereby normalizes the positioning of the posterior annulus, enabling proper closing of the valve.
Hereafter, the helix ring implantation is performed using an atrial transseptal approach. The ring is inserted through a delivery catheter by placing the leading tip at the posterior commissure, before rotating through 360 degrees.
In its final position (with one loop on the atrial side of the annulus and the other on the ventricular side) the memory material-based helix implant self-fixes by “biting” with barbs.
After implantation, the annulus position is restored and the valve closes normally. The posterior ring is redressed (as after surgery), and the reverse remodeling process may be initiated.
Experiments have shown that within 2-3 months the implant has healed in place. The stable positioning of the helix ring is expected to provide long-term benefit, with patients that experience future leaflet problems easily treatable via valve-in ring procedures.