Sahajanand Medical Technologies (SMT) has announced that its Hydra Transcatheter Aortic Valve Replacement (TAVR) system has received approval from the Singapore Health Sciences Authority (HSA). This approval marks a significant development in Hydra’s international adoption, with recent achievements across Europe and Asia, including its success in Italy’s national tender, Consip.
The Hydra TAVR system offers a distinct design, featuring two sets of markers on its frame to guide implantation depth, reducing the need for contrast during the procedure. Its large open cells allow for straightforward coronary access, facilitating ongoing patient management. With bovine pericardium and supra-annular valve positioning, the system aims to achieve a larger orifice area, providing high-level hemodynamic performance with low gradients. Hydra’s flexible design aids in navigating the aortic arch, addressing a common challenge in TAVR procedures.
Anil Suri, Vice President of APAC Commercial at SMT, stated, “Singapore is a highly regulated market, and securing approval from the Health Sciences Authority reaffirms the quality and efficacy of the Hydra valve system. Our continued global expansion reflects our unwavering commitment to making advanced cardiovascular care accessible to patients worldwide.”
The Hydra system has consistently shown strong clinical outcomes, with recent three-year results from the Hydra CE study reinforcing its effectiveness. These outcomes include sustained low, single-digit gradients over three years, along with a larger effective orifice area, demonstrating the valve’s performance. The Genesis study, published in Catheterization and Cardiovascular Interventions in 2021, further supported Hydra’s efficacy, highlighting low pacemaker rates. Together, the findings from Hydra CE and Genesis studies underscore the valve’s clinical benefits for patients.
Ammad Shorbaji, Vice President of Regulatory Affairs at SMT, commented, “Singapore’s Health Sciences Authority is recognised globally for its rigorous regulatory standards, which are modelled on international best practices. This approval underscores Hydra’s ability to meet the scrutiny of the world’s top regulators.”