SMT’s Hydra TAVR System Approved in Singapore

November 11, 2024—Sahajanand Medical Technology Pvt Ltd (SMT), which is based in Mumbai, India, recently announced that its Hydra transcatheter aortic valve replacement (TAVR) system has received approval from the Singapore Health Sciences Authority. Hydra is a resheathable, repositionable, and retrievable self-expanding valve.

According to SMT, the Hydra TAVR system features two sets of markers on the frame that guide implantation depth with precision, reducing the need for contrast; and large open cells that facilitate easy coronary access. Its bovine pericardium and supra-annular valve positioning help achieve a larger orifice area, delivering hemodynamic performance with low gradients. Hydra’s flexible design helps navigate the aortic arch with relative ease, noted the company.

European CE Mark approval of the Hydra TAVR 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.

SMT advised that the valve’s clinical excellence and benefits for patients are supported by a combination of the European HYDRA CE study results with findings from Genesis 1 and 2 studies. The recent 3-year results from the Hydra CE study reinforce evidence of the device’s strength and confirm sustained low, single-digit gradients over 3 years, paired with a larger effective orifice area, further highlighting its performance.

In January 2022, the company announced the publication of data from the Hydra CE study by Professor Audrius Aidietis, MD, et al in Journal of American College of Cardiology: Cardiovascular Interventions (2022;15:93-104). The findings evaluate the 30-day and 1-year safety and performance of the Hydra device in the treatment of symptomatic severe aortic stenosis in cardiac patients at high or extremely high surgical risk.

Additionally, the company announced in May 2024 that the 30-day safety and efficacy results from the GENESIS-II study of Hydra were presented by Nagendra Boopathy Senguttuvan, MD, at the EuroPCR 2024 conference in Paris, France. SMT announced in May 2021 that the 6-month follow-up results of GENESIS study—validating Hydra’s efficacy with low pacemaker rates—were published by Praveen Chandra, MD, et al in Catheterization and Cardiovascular Interventions.