SMT's Hydra TAVR Valve Demonstrates Sustained Safety, Durability, and Hemodynamic Performance at 5 Years

Mumbai, Maharashtra, India (NewsVoir) Sahajanand Medical Technologies’ (SMT) TAVR product Hydra’s 5-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 durable valve performance, sustained hemodynamic improvement, and favourable safety profile in patients with severe aortic stenosis.

The Hydra CE Study, led by Prof. Audrius Aidietis (Vilnius University Hospital Santaros Clinics, Lithuania) and Prof. Adam Witkowski (National Institute of Cardiology, Warsaw, Poland), was a prospective, multicenter clinical trial that enrolled 157 patients across Europe. Of these, 54 patients from Lithuania and Poland were followed for up to 5 years, providing valuable long-term evidence on valve durability and clinical outcomes.

At 5 years, Hydra demonstrated high overall survival, low rates of disabling stroke, and durable valve performance with stable gradients and effective orifice area. Importantly, the data confirms favorable valve durability with no cases of structural valve deterioration requiring reintervention, underscoring Hydra’s consistent long-term performance.

The primary endpoint of the long-term cohort was all-cause mortality at 5 years.

Secondary endpoints included cardiovascular mortality, stroke, permanent pacemaker implantation, paravalvular leak, hemodynamic performance (mean gradient and effective orifice area), 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 ischemic attacks. Permanent pacemaker implantation occurred in 16.7% of patients, and notably, no moderate or severe paravalvular leak was observed, at 5 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