Abbott, a global healthcare company, on Tuesday, announced that it has launched its latest-generation transcatheter aortic valve implantation (TAVI) system, Navitor, making the minimally invasive device available for people in India with severe aortic stenosis who are at high or extreme surgical risk.
According to the company, the Navitor valve, company is advancing transcatheter aortic valve replacement (TAVI or TAVR) 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, the company stated.
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, it can also lead to 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, the company claims.
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.
“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. 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,” said Payal Agrawal, General Manager, Emerging Asia and Korea, Abbott in a statement.
According to the company, 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.
It also claimed that 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, it stated.
“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 company said in a statement.