Addressing the Growing Need for TAVI in Russia
TAVI procedures are increasingly gaining traction in Russia as an effective, minimally invasive solution for severe aortic stenosis. Hydra™ has been designed to meet the unique clinical needs of this growing patient population, reflecting SMT’s ongoing commitment to advancing healthcare through technology.
“Russia’s medical community has shown significant interest in adopting TAVI technologies, and Hydra™ is a meaningful addition to the solutions available for treating complex cases,” said Mr. Sergey Antonov, Head of Commercial Operations for Russia. “Our entry into the market reinforces SMT’s dedication to supporting physicians with devices that combine precision, flexibility, and reliability.”
Key Features of Hydra™ TAVI System
Hydra™ is designed with features that address critical needs during aortic valve replacement procedures:
- Adaptable Design for Precision: Re-sheathable, re-positionable, and retrievable technology enables greater confidence during valve placement.
- Supra-Annular Valve Configuration: Allows for enhanced blood flow dynamics, helping to optimize post-procedure outcomes.
- Frame Markers for Deployment Guidance: Integrated markers aid physicians in achieving accurate valve placement during implantation.
- Patient-Centric Safety Features: A sealing skirt minimizes paravalvular leaks, while the stent frame design reduces interference with the conduction system, contributing to procedural safety.
- Facilitated Future Coronary Access: Open-cell design simplifies access to coronary arteries for future interventions, supporting long-term care.
Regulatory Approval by Roszdravnadzor
“In Russia, medical devices are regulated by Roszdravnadzor (The Federal Service for Surveillance in Healthcare). This agency oversees the registration, monitoring, and quality control of medical devices to ensure their safety and efficacy for use within the Russian Federation. We are very proud that Hydra is now approved in Russia which has its own strict regulatory requirements”, Added Mr. Ammad Shorbaji, Head of regulatory Affairs at SMT.
Hydra™ in the Russian Market
Hydra™ enters the Russian market at a pivotal time, with TAVI gaining widespread recognition for its ability to address complex cardiac cases. SMT’s presence in Russia, established through its successful Supraflex Cruz™ drug-eluting stent system, now expands to structural heart disease solutions with Hydra™. This aligns with SMT’s mission to bring advanced cardiovascular care to patients worldwide.
