- Latest-generation TAVI system features advancements to reduce or eliminate risk of blood leakage around valve implant
- The non-surgical Navitor TAVI system offers best-in-class deliverability and access through small vessels, expanding treatment options for patients with severe aortic stenosis
MUMBAI, India, 06 December, 2022 — Global healthcare company, Abbott today announced that it has launched its latest-generation transcatheter aortic valve implantation (TAVI) system, NavitorTM, making the minimally invasive device available for people in India with severe aortic stenosis who are at high or extreme surgical risk. With the Navitor valve, the company is advancing TAVI (also referred to as TAVR, or transcatheter aortic valve replacement) therapies with innovations including a unique design to prevent blood leaking around the valve. The Navitor TAVI system is the latest addition to the company's comprehensive structural heart transcatheter portfolio that offers physicians and patients less invasive options to treat heart diseases.
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 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 severe, symptomatic aortic stenosis.2 For these 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 lives of patients with this debilitating condition.
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.
"For people in India suffering from aortic stenosis and unable to have surgery, this TAVI system offers a safe and effective treatment option. The size ranges allow for patient-specific sizing and optimal valve function," said Dr. Ashok Seth, Chairman Fortis Escorts Heart Institute and Chairman Fortis Medical Council, New Delhi. "While transcatheter valve replacement has for some time been a standard of care for elderly patients with a narrowing of the aortic valve, this device helps to address challenges we sometimes find in current TAVI systems when we encounter challenging patient anatomies which may lead to potential problems and difficulties."
Dr Praveen Chandra, Chairman - Interventional & Structural Heart Cardiology, Medanta, Gurgaon, said, “ Aortic valve replacement can be a challenging procedure for people with complications such as age or comorbidities. For such people, a minimally invasive procedure is beneficial. This TAVI system offers important design advantages, helping us with accurate placement and easy access to the coronary arteries for any future interventions, if required. These attributes help with better patient outcomes, even across challenging anatomies.”
Dr Ravinder Singh Rao, Interventional and Structural Cardiologist, Lilavati Hospital, Mumbai and Chairman RHL Heart Centre & Head Complex Angioplasty – TAVI Program aid, “TAVI or transcatheter aortic valve implantation is a viable option for patients with severe, symptomatic aortic stenosis, especially those who have high surgical risk. After a transcatheter procedure, a vast majority of our patients are able to go home in a couple of days. What is especially good for physicians is the flexible catheter enabling excellent deliverability even in patients with complex anatomies.”
Navitor features a unique fabric cuff (NaviSeal™) that works with the cardiac cycle to reduce or eliminate a backflow of blood around the valve frame known as paravalvular leak (PVL), a common complication following TAVI procedures. The new device is the only self-expanding TAVI system with intra-annular (within the native valve) leaflets and large frame cells – features designed to help improve access to critical coronary arteries to facilitate future interventions to treat coronary artery disease (CAD). The new design additionally provides improved hemodynamics, or better blood flow.
The Navitor device is implanted with Abbott's FlexNav delivery system, which offers a slim design with the lowest TAVI delivery system profile, allowing treatment of people with vessels as small as 5.0 mm. The slim catheter can accommodate different aortic anatomies for stable, predictable and accurate valve delivery and placement.
"The innovative design of the Navitor valve paired with the FlexNav delivery system streamlines and simplifies TAVI procedures for physicians and helps with better valve placement and performance for patients, giving them a more robust set of solutions to treat this condition,” said Payal Agrawal, General Manager, Emerging Asia and Korea, Abbott. “This latest and important product represents another milestone in Abbott’s mission to provide the most comprehensive treatment options to address cardiovascular conditions and improve quality of life so people can get back to doing the things they love," she added.
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, nutritionals and branded generic medicines. Our 113,000 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.
Connect with us at www.abbott.com and www.abbott.in, on Facebook at www.facebook.com/Abbott and www.facebook.com/AbbottIndia, and on Twitter @AbbottNews.
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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.
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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.