Singapore Approves Novel Hydra TAVI System

The Hydra TAVR system is unique in the market due to its advanced features, such as two sets of markers on the frame that guide implantation depth with precision, reducing the need for contrast. Its large open cells facilitate easy coronary access, ensuring patients benefit from better lifetime management. The bovine pericardium and supra-annular valve positioning help achieve a larger orifice area, delivering industry-leading hemodynamic performance with low gradients. Hydra’s innovative flexible design helps navigate aortic arch with relative ease, a common challenge in TAVR procedures.

Anil Suri, Vice President of APAC Commercial at SMT, commented, “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.”

Hydra has consistently demonstrated remarkable clinical outcomes, with the recent 3-year results from the Hydra CE study reinforcing its strength. These results confirm sustained low, single-digit gradients over three years, paired with larger effective orifice area, further highlighting its performance. Moreover, the Genesis study, published in Catheterization and Cardiovascular Interventions in 2021, also validated Hydra’s efficacy with low pacemaker rates. The combination of Hydra CE’s 3-year results with the findings from Genesis 1 and 2 studies clearly showcases the valve’s clinical excellence and the significant benefits it brings to patients.

Ammad Shorbaji, Vice President of Regulatory Affairs at SMT, emphasized, “Singapore’s Health Sciences Authority is recognized 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.”