AnchorValve TMVR Solutions
The integrated one-unit AnchorValve TMVR
The AnchorValve two-step TMVR docking platform
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Potential Advantages of AnchorValve’s TMVR Technologies
Firm anchoring at and all around the mitral valve annulus, minimising the risk of para-device leakage
Proprietary clamping technology for thin tissues at mitral anterior side
Low risk for LVOTO, because the valved-stent is positioned at the annular level, away from the left ventricle
Relatively simple implantation procedures, with no requirement to go around the valve, leaflets, or chordae
Leaves mitral valve leaflets able to move freely, with no or less need for life-time anticoagulation expected
Flanges can compensate for large size valve annulus, one size (27 mm) valve prosthesis feasible
Small compressed diameters enable transseptal delivery by the cardiologist alone
Atrial septal closure device unlikely to be needed
Broadly applicable patient selection criteria
Can also be used for tricuspid valve replacement
Granted EU and US patents
Current status of competing products
Since the clinical introduction of competing TMVR devices in 2014, just a few hundred patients have received TMVR devices worldwide. Reasons for the low inclusion rates are reported to be a too large or too small valve annulus dimension and LVOT obstruction (LVOTO). Other complications that may occur are: para-device leakage, transapical approach complications, and the requirement for separate septal closure devices if used transseptally.
Most competing companies have developed complete one-step TMVR devices that are positioned deeply, and often completely, inside the left ventricle. More recently, two-step transseptal docking systems have been developed, but most of these require more complicated implantation procedures where the docking system is still located below the mitral annulus, forcing the valved-stent still deeply inside the left ventricle. To date, such two-step TMVR devices have still resulted in elevated risks of left ventricular outflow tract (LVOT) obstruction and still suffer low clinical inclusion rates.
Our strategy is to further develop a transseptally deployed annular anchored transcatheter TMVR and TTVR valve, and also a docking platform for mitral and tricuspid valve replacement, compatible with a broad range of transcatheter delivered valved-stents, whether balloon or self expandable.
Thanks to its proprietary unique design, AnchorValve’s TMVR valve and Docking Platform anchors all around and only at the level of the mitral valve origin (annulus), positioning the valved-stent between the left atrium and ventricle, while most competing one- and two-step products are almost completely located inside the left ventricle.
AnchorValve's TMVR and docking technology is expected to have demonstrably superior cardiac haemodynamic performance, freedom from mitral regurgitation, and freedom from LVOT obstruction.
By elongating the flanges of the anchoring mechanism, the TMVR and Docking Platform may be adapted to larger sizes of the mitral valve, while using one size of valve prosthesis. AnchorValve’s TMVR and Docking Platform technology allow the mitral valve leaflets to move freely, with reduced need for life-time anticoagulation.
The Docking Platform will create only a small puncture hole in the atrial septum, and hence will minimise the need for a separate septal closure device, as required with many completing transseptal TMVR devices.
With sufficient funding, our goal is to reach FIM implantation within 2 years.