Key findings reveal the Hydra THV’s outstanding safety and efficacy, with a low cardiovascular mortality rate of 2.5 per cent and a high device success rate of 95 per cent at 30 days post-intervention.
Sahajanand Medical Technologies (SMT), an innovator in cardiovascular medical device technology announces findings from the GENESIS-II study evaluating the Hydra self-expanding transcatheter aortic valve (THV).
Dr Nagendra Boopathy Senguttuvan of Sri Ramachandra Hospital, Chennai, Tamil Nadu, showcased the study’s 30-day results during the TAVI Hotline session at EuroPCR 2024.
“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.,” says Dr John Jose, Study lead & Principal investigator on the trial.
Spanning 19 sites throughout India and involving a cohort of 40 patients diagnosed with severe aortic stenosis and classified as high surgical risk, the GENESIS-II study was designed to evaluate the continuous safety and performance of the Hydra THV. The study, a prospective, multicenter, non-randomised investigational endeavour, enrolled patients from November 01, 2021, to November 10, 2023.
Key findings from the study reveal that at 30 days post-intervention, the Hydra THV demonstrated a cardiovascular mortality rate of 2.5 per cent and a new permanent pacemaker implantation incidence of 7.9 per cent.
According to the company’s statement, “Notably, no clinical events related to secondary endpoints were observed, and the device success rate stood impressively at 95 per cent. Furthermore, significant improvements were noted in parameters such as effective orifice area and mean aortic valve gradient, along with favourable enhancements in New York Heart Association (NYHA) functional class.”
Elaborating on the results, TAVR specialist, Dr Anmol Sonawane from Breach Candy Hospital, who played a role as principal proctor in this study, remarked, “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.
Adding to his views, chief medical officer in SMT, Dr Krishna Sudheer ascertains, “At 30-day follow up, the GENESIS II trial showed excellent clinical outcomes for the Hydra THV, now with a novel active release mechanism for deploying the valve. These results add to earlier data from the GENESIS and the CE Mark trials, confirming the safety and performance of SMT’s TAVI device in the treatment of severe aortic stenosis in patients at high surgical risk.”