SMT’s HYDRA CE Study of Hydra Transcatheter Aortic Heart Valve Published

January 19, 2022—Sahajanand Medical Technologies Limited (SMT) announced the publication of data from the HYDRA CE study evaluating the 30-day and 1-year safety and performance of the company’s Hydra transcatheter aortic heart valve (THV) in the treatment of symptomatic severe aortic stenosis in cardiac patients at high or extremely high surgical risk.

European CE Mark approval of the Hydra valve system was announced in June 2020. The device is also approved in several countries in Asia to treat patients with symptomatic, severe aortic stenosis who are at high or extreme risk for open heart surgery.

Professor Audrius Aidietis, MD, et al published the HYDRA CE study in Journal of American College of Cardiology: Cardiovascular Interventions (2022;15:93-104).

According to SMT, the HYDRA CE Study demonstrated that transcatheter aortic valve replacement (TAVR) with Hydra THV offered favorable efficacy at 1 year, providing a large effective orifice area and low transvalvular gradient, as well as acceptable complication rates.

The multicenter study, which enrolled 157 patients (mean age, 80 years) at 18 medical centers in Europe and in Asia-Pacific countries, was led by Professor Lars Søndergaard, MD, with Rigshospitalet in Copenhagen, Denmark.

Prof. Søndergaard commented in SMT’s press release, “The Hydra THV system is designed to overcome some of the limitations of existing devices for [TAVR]. The delivery system has a low profile and is very flexible, which allows for transfemoral access even in challenging anatomies.”

Prof. Søndergaard continued, “Furthermore, the THV is based on self-expanding technology with supra-annular leaflet position, which provides optimal hemodynamic performance. The stent frame design with large cells allows for easy access to the coronary arteries, and the part in the left ventricle outflow tract has little interference with the conduction system. In addition, it is possible to resheath and reposition the THV, which allows for more accurate deployment. Therefore, the Hydra THV system offers several advantages compared to existing systems.”

In May 2021, the company announced that the 6-month follow-up results in the GENESIS study of the Hydra device were published by Praveen Chandra, MD, et al in Catheterization and Cardiovascular Interventions. GENESIS evaluated Hydra’s safety and performance in 40 patients enrolled at 11 centers in India and was used to support regulatory approval of the device in India.