SMT’s Hydra THV Evaluated in 30-Day Safety and Efficacy Data From GENESIS-II

May 24, 2024—Sahajanand Medical Technologies (SMT), a Mumbai, India-based cardiovascular device technology company, recently announced findings from the GENESIS-II study, which is evaluating the company’s self-expanding Hydra transcatheter heart valve (THV) device for transcatheter aortic valve implantation/replacement (TAVI/TAVR). European CE Mark approval of the Hydra valve system was announced in June 2020.

The GENESIS-II 30-day results were presented by Nagendra Boopathy Senguttuvan, MD, of Sri Ramachandra Hospital, Chennai, India, during the TAVI Hotline session at the EuroPCR 2024 conference, which was held May 14-17 in Paris, France.

According to the company, prospective, multicenter, nonrandomized GENESIS-II study was designed to evaluate the continuous safety and performance of the Hydra THV. The study was conducted at 19 sites in India. Investigators enrolled 40 patients diagnosed with severe aortic stenosis and classified as high surgical risk from November 1, 2021, to November 10, 2023.

SMT stated that at 30 days postintervention, the Hydra THV device demonstrated a cardiovascular mortality rate of 2.5% and a new permanent pacemaker implantation incidence of 7.9%. No clinical events related to secondary endpoints were observed, and the device success rate was 95%. Additionally, significant improvements were noted in effective orifice area and mean aortic valve gradient, as well as New York Heart Association functional class.

The study is led by Principal Investigator John Jose, MD, a professor of cardiology at Christian Medical College in Vellore, India. Anmol Sonawane, MD, a TAVR specialist at Breach Candy Hospital in Mumbai, India, served as Principal Proctor in this study.

“GENESIS II demonstrated impressive safety and efficacy results for the Hydra THV, with low mortality, significant reductions in valve gradients, and minimal paravalvular leak at 30 days,” commented Dr. Jose in SMT’s press release. “We look forward to the longer-term results from this trial, an important addition to available data on this promising TAVI technology from India.”

Dr. Sonawane added, “The modification of the Hydra delivery system with a novel active release mechanism has significantly eased device deployment. Clinical outcomes have notably improved, with lower 30-day mortality compared to the earlier GENESIS trial, and acceptable complication rates. The Hydra THV represents a promising new technology in patients with severe aortic stenosis.”