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June 5, 2020

SMT’s Hydra TAVR System Receives CE Mark Approval

June 5, 2020—Sahajanand Medical Technology Pvt Ltd (SMT) announced that the company’s Hydra transcatheter aortic valve replacement (TAVR) device received European CE Mark approval for the treatment of patients with aortic stenosis.

According to the company, the Hydra aortic valve is a self-expandable nitinol-based supra-annular aortic system. The device features a mechanism for recapturing the valve during deployment, which helps in precise placement of the valve and ensures orthotopic deployment. Hydra is available in three sizes: 22, 26, and 30 mm, and is selected depending upon the diameter of the native annulus from 18 to 27 mm.

The Hydra system’s ability to eliminate significant aortic regurgitation was confirmed by clinical data from the Genesis trial conducted in India and presented at the India Valves Conference 2019 in Chennai, India.

CE Mark approval was supported by a European clinical study composed of 110 patients enrolled until February 2020 that demonstrated a strong safety profile for the Hydra device.

Professor Lars Søndegaard, MD, who served as principal investigator of the trial, commented in SMT’s announcement, “Hydra is a novel transcatheter heart valve for the treatment of patients with severe aortic stenosis. Features that favor this self-expanding technology with the supra-annular position of the leaflet include small size delivery system allowing transfemoral access despite small access vessels, flexible system favoring challenging anatomies, such as tortuous anatomy and horizontal aorta, large efficient orifice area of the valve, and low rate of paravalvular leakage and pacemaker.”

Prof. Søndegaard added, “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.”

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