Hydra is the first TAVR device to incorporate frame markers, ensuring precise implantation and ease of deployment
Mumbai-based Sahajanand Medical Technologies (SMT) has launched Hydra Transcatheter Aortic Valve Replacement (TAVR) system in Mexico.
The Hydra TAVR system features advanced innovations, including:
- Frame Markers: Hydra is the first TAVR device to incorporate frame markers, ensuring precise implantation and ease of deployment.
- Supra-Annular Design: This enhances hemodynamic performance, delivering a larger effective valve area for improved patient recovery and quality of life.
- Bovine Pericardium: The valve is crafted with high-quality bovine pericardium for durability and reliability.
- Reduced Trauma Design: Hydra’s flexible frame reduces trauma to the aortic arch, while its sealing skirt minimises paravalvular leaks for improved safety.
- Future-Proof Access: Large open cells in the stent frame ensure easy coronary access for future interventions.
“With the approval of Hydra in Mexico, we are empowering physicians with an advanced TAVR system that combines precision, safety, and superior hemodynamics,” said Joao Rodrigues, Head of Latin America at SMT. “This milestone underscores our commitment to saving lives and transforming cardiac care in Latin America.”
Hydra’s approval by COFEPRIS, Mexico’s Federal Commission for Protection Against Sanitary Risks, is a testament to SMT’s dedication to meeting stringent regulatory requirements. COFEPRIS is recognised for its rigorous evaluation standards, ensuring the safety and efficacy of healthcare technologies introduced in the Mexican market.
“It is expected that COFEPRIS requires comprehensive technical and clinical data for product registration, which after several rounds of reviews SMT successfully addressed and provided the agency with all required technical and clinical studies We are incredibly proud of this achievement,” added Ammad Shorbaji, Vice President of Regulatory Affairs, SMT.
