Sahajanand Medical Technologies (SMT), a global leader in innovative cardiovascular solutions, has recently expanded its Hydra Transcatheter Aortic Valve Replacement (TAVR) system into the Mexican market. This strategic move underscores SMT’s commitment to providing advanced, minimally invasive cardiac care to patients worldwide.
Transcatheter is being driven by the rising population of elderly people and growing demand for minimal-invasive processe
Addressing Mexico’s Growing Cardiac Care Needs
Mexico plays a pivotal role in the Latin American TAVR market, which was projected to reach $350 million in 2024 and is expected to grow at a compound annual growth rate (CAGR) of over 20% through 2029. This surge is driven by an aging population, an increasing prevalence of aortic stenosis, and a rising preference for minimally invasive procedures. The introduction of the Hydra TAVR system aims to meet these demands by offering a solution designed for precision, safety, and optimal patient outcomes.
Innovative Features of the Hydra TAVR System
The Hydra TAVR system is distinguished by several advanced features:
Frame Markers: It is the first TAVR device to incorporate frame markers, ensuring precise implantation and ease of deployment.
Supra-Annular Design: This design enhances hemodynamic performance, providing a larger effective valve area, which contributes to improved patient recovery and quality of life.
Bovine Pericardium: The valve is constructed using high-quality bovine pericardium, known for its durability and reliability.
Reduced Trauma Design: The flexible frame minimizes trauma to the aortic arch, and the sealing skirt reduces the risk of paravalvular leaks, enhancing patient safety.
Future-Proof Access: Large open cells in the stent frame facilitate easy coronary access for potential future interventions.
Joao Rodrigues, Head of Latin America at SMT, stated, “With the approval of Hydra in Mexico, we are empowering physicians with an advanced TAVR system that combines precision, safety, and superior hemodynamics. This milestone underscores our commitment to saving lives and transforming cardiac care in Latin America.”
Regulatory Approval and Global Expansion
The Hydra TAVR system received approval from COFEPRIS, Mexico’s Federal Commission for Protection Against Sanitary Risks. This approval reflects SMT’s dedication to meeting stringent regulatory standards, ensuring the safety and efficacy of its healthcare technologies. Ammad Shorbaji, Vice President of Regulatory Affairs at SMT, noted, “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.”
The launch in Mexico is part of SMT’s broader strategy to expand access to high-quality cardiovascular solutions globally. The Hydra TAVR system is now available in over 20 countries, revolutionizing structural heart care by providing physicians with a reliable, re-sheathable, re-positionable, and retrievable TAVR system.
Clinical Validation and Future Prospects
Clinical studies have demonstrated the efficacy and safety of the Hydra TAVR system. An analysis published in JACC: Cardiovascular Interventions in 2022 tracked data from 157 patients with a mean age of 79.2 years. The study reported a device success rate of 82.8%, an all-cause mortality rate of 14.6%, and significant improvements in both effective orifice area and mean aortic valve gradient. The researchers advocated for further studies to evaluate the device’s safety and effectiveness, particularly in low-risk patients and those with bicuspid aortic valves.
In addition to its expansion into Mexico, the Hydra TAVR system has gained approvals in other regions. In October 2024, Singapore’s Health Sciences Authority (HSA) approved the Hydra TAVR system, marking a significant milestone in its global adoption. This approval underscores the system’s quality and efficacy, meeting the rigorous regulatory standards modeled on international best practices.
The Hydra TAVR system has also been introduced in Hungary, with initial procedures yielding positive outcomes. The debut at Szegedi Tudományegyetem Szent-György Albert Klinikai Központ, under the leadership of Dr. Ruzsa Zoltán and Dr. Szücsborús Tamás, marked a significant advancement in minimally invasive treatments for aortic stenosis.
Gaurav Goel, President of SMT’s Hydra business, expressed enthusiasm about the expansion, stating, “With the successful launch of Hydra in Hungary, SMT has further expanded its global TAVI program. We are thrilled with the positive feedback received, and it inspires us to keep on innovating and creating a positive impact on patient healthcare.”
About SMT (Sahajanand Medical Technologies)
SMT is a global leader in cardiovascular medical devices, specializing in drug-eluting stents and structural heart disease solutions. Operating in over 80 countries, SMT is dedicated to advancing patient care through innovative medical technologies and clinical excellence. The company’s commitment to innovation is exemplified by its pioneering introduction of biodegradable polymers in the cardiovascular segment and its recognition from the Ministry of Health Sciences & Technologies for contributions to coronary healthcare.
