Sahajanand Medical Technology (SMT) announced today that its Hydra TAVR device has received the CE Mark for the treatment of severe aortic stenosis.
The Hydra aortic valve is a self-expandable, nitinol-based, supra annular aortic system with a mechanism for recapturing the valve during deployment, according to Mumbai, India-based SMT. This property helps in precise placement of the valve and ensures orthotopic deployment, the company added.
The non-flared inflow section of the frame and supra-annular valve leaflet design are intended to ensure better aortic valvular area in smaller annuli and in valve-in-valve settings. The frame has 3 tentacles or antennae for better anchorage and larger cells (10mm) for better access in future coronary interventional procedures. The delivery cable is highly flexible and 18 French-compatible, and the device can be recaptured, repositioned and retrieved even after 85% to 90% of deployment, according to SMT.