Abbott Launches Navitor™, its Latest-Generation Transcatheter Aortic Valve Implantation (TAVI) System to Treat Aortic Stenosis in India

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Jaipur,December 2022.

Global healthcare company, Abbott today announced that it has launched its latest-generation transcatheter aortic valve implantation (TAVI) system, Navitor™, makingthe minimally invasive device availablefor people in India with severeaortic stenosis who are at high or extreme surgical risk.With the Navitorvalve, 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 NavitorTAVI system is the latest addition to the company'scomprehensivestructural heart transcatheter portfolio thatoffers physicians and patients less invasive options to treatheart 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.While many people don’t have noticeable symptoms, in India, one in 40 people aged 75 and older have severe, symptomatic aortic stenosis.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. 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.

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 hemo dynamics, or better blood flow.

 

The Navitordevice is implanted with Abbott's Flex Navdelivery system, whichoffers a slim design with the lowest TAVI delivery system profile, allowing treatment of peoplewith vessels as small as 5.0 mm. The slim catheter can accommodate different aorticanatomies for stable, predictable and accurate valve delivery and placement.

"The innovative design of the Navitor valve paired with the FlexNav delivery system streamlines and simplifiesTAVI 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.