Medtronic has strengthened its cardiac surgery portfolio in India with the launch of the Avalus™ Ultra Bioprosthesis valve, representing a major advancement in surgical aortic valve replacement (SAVR) technology. Designed with a low-profile structure, flexible sewing cuff, and enhanced fluoroscopic visibility, the Avalus Ultra builds on a decade of proven performance from the Avalus platform to offer surgeons greater ease of implantation, long-term durability, and readiness for future valve-in-valve procedures.
Supported by clinical evidence from the PERIGON Pivotal Trial, the valve demonstrates outstanding durability and stable hemodynamics through seven years of follow-up. This innovation underscores Medtronic’s commitment to bringing cutting-edge cardiac solutions to India while empowering healthcare professionals with robust training and educational programs.
In an exclusive interaction with MedTech Spectrum, Prateek Tiwari, Senior Director Neuroscience & Speciality Therapies at Medtronic, discusses the technology behind Avalus Ultra, its role in lifetime patient management, and how Medtronic is working to expand access to advanced cardiac care across India.
What does the launch of the Avalus Ultra Bioprosthesis valve in India represent for Medtronic’s broader cardiac surgery portfolio and commitment to advancing heart valve therapies in the region?
The introduction of the Avalus™ Ultra Bioprosthesis valve in India is a pivotal step forward for the cardiac surgery portfolio of Medtronic and underscores our unwavering commitment to advancing heart valve therapies across the region. This launch demonstrates our dedication to driving meaningful innovation, expanding patient access, and investing in comprehensive education for clinicians.
By bringing the Avalus Ultra valve to India, Medtronic is delivering global technology to local market, empowering cardiac surgeons with the tools, training, and support needed to achieve predictable and durable outcomes for their patients. Our commitment extends beyond technology; we are fostering clinical collaboration and providing robust training programs to ensure that every advancement is matched with clinical excellence and capacity building.
Through initiatives like this, Medtronic continues to fulfill its mission to alleviate pain, restore health, and extend life by delivering transformative healthcare solutions for India.
The Avalus Ultra builds on a decade of clinical experience with the Avalus platform. Could you elaborate on the key innovations or design enhancements that make this next-generation valve unique for both clinicians and patients?
The Avalus Ultra bioprosthetic valve1 represents a significant advancement in valve technology, built on a decade of clinical experience with the Avalus platform. It is engineered for ease of implantation and long-term patient management, featuring a low-profile design that accommodates a wide range of anatomies. The valve includes a flexible sewing cuff that promotes secure seating and minimizes paravalvular leak rates, while replica sizers with simulated cuffs aid in precise sizing. For future transcatheter aortic valve-in-surgical valve (TAV-in-SAV) procedures, the Avalus Ultra offers a durable circular foundation and incorporates platinum-iridium coils and a tantalum badge to enhance fluoroscopic visibility, ensuring accurate placement and secure positioning during reinterventions.
Durability and long-term patient outcomes are critical for surgical heart valve replacements. How does the Avalus Ultra address these aspects, and what insights have emerged from the PERIGON Pivotal Trial and other clinical data?
At Medtronic, we recognize that durability and long-term patient outcomes are essential for surgical heart valve replacements. The Avalus™ Ultra valve is engineered to deliver durability and sustained clinical performance; empowering clinicians and offering patients peace of mind.
Backed by our trusted AOA™ tissue treatment technology, which has supported over half a million patients for more than three decades, Avalus Ultra builds on a legacy of reliability. Clinical evidence from the PERIGON Pivotal Trial reinforces this legacy, demonstrating 99% 2freedom from structural valve deterioration (SVD) and severe hemodynamic dysfunction (SHD) requiring reintervention through seven years of follow-up. These results highlight the valve’s stable hemodynamic and excellent durability.
With more than 10 years of clinical experience supporting the Avalus platform, Avalus Ultra continues to set the standard for effective orifice area, low gradients, and robust performance. By bringing this proven technology to India, Medtronic is committed to providing patients and clinicians with advanced solutions for lasting results fulfilling our mission to deliver reliable, innovative therapies that restore health and extend life.
One of the valve’s highlights is its compatibility for future TAV-in-SAV reinterventions. How does this feature support lifetime management for patients and help surgeons plan for long-term treatment pathways?
At Medtronic, we understand that lifetime management is vital for patients undergoing heart valve surgery. The Avalus™ Ultra valve is purposefully designed to support future transcatheter aortic valve-in-surgical aortic valve (TAV-in-SAV) reinterventions, empowering clinicians to plan for patients’ long-term care.
Avalus Ultra offers a durable, circular foundation and reliable performance that seamlessly accommodates evolving treatment pathways. Its low-profile design suits a wide range of patient anatomies, providing flexibility at initial implant and throughout the patient’s journey. For valve-in-valve procedures, the platinum-iridium coil and tantalum badge significantly enhance fluoroscopic visibility, enabling accurate placement and secure positioning during reinterventions.
From day one, Avalus Ultra is engineered for lasting compatibility and future readiness, helping surgeons deliver optimal outcomes at every stage. With this innovation, Medtronic continues to advance our mission to restore health and extend life by supporting clinicians in the lifelong management of their patients.
Could you discuss how Medtronic is supporting Indian healthcare professionals with training, education, and clinical resources to ensure optimal outcomes with the Avalus Ultra valve?
At Medtronic, we are deeply committed to empowering Indian healthcare professionals with the knowledge and resources they need to deliver exceptional patient care with the Avalus™ Ultra valve. Our comprehensive support includes structured education programs, hands-on workshops, and device-specific surgical guides and videos all designed to enhance clinical expertise and confidence. We offer in-service demonstrations, and proctorships with renowned experts to foster peer-to-peer learning and collaboration. Through continuing medical education events and robust local clinical partnerships, Medtronic is dedicated to shortening the learning curve and driving consistent, evidence-based outcomes for patients across India.
Looking ahead, how do you see surgical aortic valve replacement evolving in India, and what role will technologies like Avalus Ultra play in expanding access to advanced cardiac care?
As we look to the future of cardiac care in India, Medtronic recognizes that surgical aortic valve replacement (SAVR) will remain a cornerstone of treatment for many patient groups including those with complex anatomy and younger individuals despite the growing adoption of transcatheter aortic valve replacement (TAVR). Both pathways are poised to evolve and expand in parallel, ensuring that patients have access to the most appropriate, evidence-based therapies. SAVR in India is set to further advance by being less invasive, more standardized, and increasingly accessible. Innovations like the Avalus™ Ultra valve are leading this transformation being less ease of handling, predictable sizing, and durable performance that empower surgeons to achieve consistent, efficient outcomes. These advancements help reduce operative time and lower technical barriers. We are committed to supporting this evolution by providing training, education, and enabling hybrid operating theatre infrastructure. By combining cutting-edge technology with robust clinical support, we are expanding access to high-quality cardiac care for patients across India.
References
1.https://news.medtronic.com/Medtronic-launches-Avalus-Ultra-TM-surgical-valves-in-India,-enhancing-cardiac-care-for-patients
