Sahajanand Medical Technologies’ (SMT) TAVR product Hydra’s five-year follow-up results from the pivotal Hydra CE Study were presented by Dr Vilhelmas Bajoras at PCR London Valves 2025. The long-term data reaffirm Hydra’s valve performance, sustained haemodynamic improvement and safety profile in patients with severe aortic stenosis.
The Hydra CE Study, led by Prof Audrius Aidietis of Vilnius University Hospital Santaros Clinics, Lithuania, and Prof Adam Witkowski of the National Institute of Cardiology, Warsaw, Poland, was a prospective, multicentre clinical trial that enrolled 157 patients across Europe. Of these, 54 patients from Lithuania and Poland were followed for up to five years, providing long-term evidence on valve durability and clinical outcomes.
At five years, Hydra demonstrated overall survival, low rates of disabling stroke and valve performance with stable gradients and effective orifice area. The data confirms valve durability with no cases of structural valve deterioration requiring reintervention.
The primary endpoint of the long-term cohort was all-cause mortality at five years. Secondary endpoints included cardiovascular mortality, stroke, permanent pacemaker implantation, paravalvular leak, haemodynamic performance, NYHA functional class improvement and the absence of structural valve deterioration, endocarditis or thrombosis.
The all-cause mortality was 24.3%, with cardiovascular mortality of 6.0%. The stroke rate was 12.2%, including two disabling and four non-disabling strokes or transient ischaemic attacks. Permanent pacemaker implantation occurred in 16.7% of patients, and no moderate or severe paravalvular leak was observed at five years.
Hydra demonstrated sustained valve function, with effective orifice area increasing from 0.68 ± 0.15 cm² at baseline to 2.09 ± 0.57 cm² (p < 0.001), and mean transvalvular gradient decreasing from 53.4 ± 14.24 mmHg to 8.0 ± 3.14 mmHg (p < 0.001). In addition, 65% of patients showed an improvement of at least one NYHA class. No valve endocarditis, thrombosis or structural valve deterioration was reported through five years.
Commenting on the study results, Prof Audrius Aidietis, Principal Investigator of the Hydra CE Study, Senior Consultant at the Cardiology and Angiology Centre and Cardiac Surgery Centre of Vilnius University Hospital Santaros Clinics, Lithuania, said, “The 5-year results highlight Hydra Valve’s sustained safety, durability and consistent clinical performance. We observed durable valve function, survival and stable hemodynamics through 5 years. These findings underscore the long-term reliability of Hydra in treating patients with severe aortic stenosis.”
Dr Vilhelmas Bajoras, Co-Investigator of the Hydra CE Study, Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania, added, “The absence of structural valve deterioration or significant paravalvular leak at 5 years is an achievement. Hydra continues to demonstrate that self-expanding TAVR technology can deliver durable outcomes and sustained clinical benefits over the long term.”
Dr Krishna Sudhir, Chief Medical Officer at Sahajanand Medical Technologies (SMT), added, “These consistent 5-year outcomes of Hydra showing excellent survival, sustained valve function, and stable hemodynamics, reaffirm our commitment to advancing cardiovascular care through engineering and evidence-based medicine. The valve’s enduring performance underscores our commitment to delivering reliable, safe, and durable TAVR solutions that advance patient outcomes across the globe.”
The five-year Hydra CE results stand as a statement of SMT’s commitment to quality-driven, research-based cardiovascular care. SMT states that it continues to focus on clinical and evidence-based medicine to deliver solutions that address patient needs worldwide, with a stated mission of saving lives and improving long-term health outcomes globally.