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.
Hydra is available in 22mm, 26mm & 30mm sizes and is selected depending upon the diameter of the native annulus from 18mm to 27mm. Clinical data from the Genesis trial conducted in India and presented at the 2019 India Valves Conference confirm the system’s ability to eliminate significant aortic regurgitation, according to the company. In another CE clinical study conducted in Europe, the Hydra system also demonstrated a strong safety profile on 110 patients enrolled until February 2020, the company added.
Hydra’s small-size delivery system allows for transfemoral access despite small access vessels, according to Dr. Lars Sondergaard of Copenhagen University Hospital, principal investigator for the European trial. The device’s flexible system makes it useful for challenging anatomy such as tortuous anatomy and horizontal aorta, he added, also counting its large efficient orifice area of the valve and low rate of paravalvular leakage as advantages, according to a news release.
“During the trials in Asia, Europe and New Zealand, more than 200 patients have benefited from the Hydra valve, and I am certain it will fill an important space in the near future,” Sondegaard added.
CE certification will enable SMT to expand its structural heart business across Europe.
”The Hydra valve has been designed to make the TAVR procedure user-friendly and to simplify the procedure with the lowest profile delivery system and a valve where the function of the valve can be observed before the final release,” said SMT founder Swaminathan Jayaraman. “The two sets of markers on the valve is a unique design which provides good visual ability to position the valve and takes the variability out of the difficulties associated with positioning in difficult anatomy.”
