NEW DELHI, January 28, 2025 – Abbott, the global healthcare company, announced the launch of Navitor Vision in India for the treatment of patients with symptomatic severe aortic stenosis who are at high or extreme surgical risk. The device is the latest iteration of the company’s Navitor transcatheter aortic valve implantation/replacement (TAVI/TAVR) system. The Navitor platform, known for its stable delivery, remarkable performance, and future readiness, has been enhanced with three large Vision markers for improved visibility and easier valve deployment during a TAVI/TAVR procedure. These markers help interventionists implant the device more accurately, while making the TAVI valve easier to see during the procedure.
Aortic stenosis is one of the most common and life-threatening heart valve diseases. It restricts blood flow through the aortic heart valve to the rest of the body, which can lead to heart failure, impaired quality of life and, in certain cases, sudden cardiac death.1 While many people don’t have noticeable symptoms, in India, one in 40 people aged 75 and older have aortic stenosis.2 Prior to TAVI, the standard of care for severe aortic stenosis was surgical aortic valve replacement, but not all patients were candidates for open-heart surgery.
Transcatheter Aortic Valve Implantation (TAVI) is a cutting-edge, minimally invasive procedure to replace a damaged aortic valve in the heart. Unlike traditional open-heart surgery, TAVI is performed through small incisions, often in the groin, which means patients can recover faster and face fewer risks. This innovation is significant because it provides a life-saving option for patients who are too high-risk for regular open-heart surgery. It also leads to quicker hospital discharges and improved patient outcomes overall. Essentially, TAVI makes heart valve replacement safer and more accessible for many people.
Neeraj Singh, country manager for Abbott’s structural heart business in India said, “For some people, open-heart surgery is considered a high-risk procedure due to the potential complications stemming from age, frailty or having multiple other diseases or conditions.3 TAVI serves as a less invasive alternative to surgical aortic valve replacement and can reduce symptoms and improve the life expectancy of patients with this condition. Abbott’s Navitor Vision valve is an important addition to our range of treatments for structural heart issues, particularly for heart valve disease and offers hope to people who may not have other treatment choices.”
The Navitor Vision valve comes in different sizes to fit heart openings (annulus) ranging from 19 mm to 27 mm and thereby fits almost all patients in need of TAVI. The device also has a dynamic sealing cuff that reduces the leaking of blood back to the heart. Navitor is implanted with Abbott's FlexNav™ delivery system, which offers a slim design, allowing treatment of people with vessels as small as 5.0 mm. The FlexNav catheter can accommodate different aortic anatomies for stable, predictable and accurate valve delivery and placement.
The Navitor valve is known for its excellent blood flow (hemodynamics) and durability. A 30-day outcome study4 showed it has a large opening area and a low mean pressure gradient across the aortic valve, meaning there's little resistance to blood flow. This indicates the valve works efficiently with minimal blockage. Furthermore, Navitor is a future ready valve with large frame cells, to facilitate easy access to the coronary arteries, making it easier to treat coronary artery disease in the future.
About Abbott:
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. In India, Abbott was established in 1910, and is one of the country's oldest and most admired healthcare companies. With more than 12,000 employees in the country, Abbott is helping to meet the healthcare needs of consumers, patients and doctors throughout urban and rural India.
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References:
1 Mayo Clinic. Transcatheter aortic valve replacement (TAVR). August 2020.
2 Osnabrugge, R. L., Mylotte, D., et al. Aortic Stenosis in the Elderly: Disease Prevalence and Number of Candidates for Transcatheter Aortic Valve Replacement: A Meta-Analysis and Modeling Study. Journal of the American College of Cardiology 2013;62(11), 1002-1012; doi: 10.1016/j.jacc.2013.05.015.
3 Bach DS, Siao D, Girard SE, Duvernoy C, McCallister BD Jr, Gualano SK. Evaluation of patients with severe symptomatic aortic stenosis who do not undergo aortic valve replacement: the potential role of subjectively overestimated operative risk. Circ Cardiovasc Qual Outcomes. 2009. November; 2 6: 533– 9.
4 Reardon, M, Chehab, B, Smith, D. et al. 30-Day Clinical Outcomes of a Self-Expanding Transcatheter Aortic Valve: The International PORTICO NG Study. J Am Coll Cardiol Intv. 2023 Mar, 16 (6) 681–689. https://doi.org/10.1016/j.jcin.2023.02.002.
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