Sam Brusco, Associate Editor05.17.21
Abbott earned CE mark for its latest-gen transcatheter aortic valve implantation (TAVI) system, Navitor, making the minimally invasive device available for people in Europe with severe aortic stenosis who are at high or extreme surgical risk. Innovations include a 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.
Aortic stenosis restricts blood flow through the aortic valve to the rest of the body, which can lead to heart failure and, in certain cases, sudden cardiac death.1 For some diagnosed with severe aortic stenosis, open-heart surgery is considered high-risk due to potential complications stemming from age, frailty, or having multiple other diseases or conditions.2 TAVI is a less invasive alternative to surgical aortic valve replacement.
"With an aging world population and with aortic stenosis cases projected to double in Europe and the U.S. in the next few decades, the need for innovative, minimally invasive solutions is critical," Lars Søndergaard, M.D., professor of Cardiology, Rigshospitalet, Copenhagen University Hospital in Denmark, who served as co-principal investigator for the global Navitor TAVI system clinical study, told the press. "While transcatheter valve replacement has for some time been a standard of care for patients with a narrowing of the aortic valve, Navitor helps to address challenges we sometimes find in current TAVI systems when we encounter complex patient anatomies that can lead to potential complications."
Navitor features a fabric cuff (NaviSeal) that works with the cardiac cycle to reduce or eliminate 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 received CE mark in 2020 and offers 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, enabling better valve placement and performance for patients so they can get back to living fuller, healthier lives," said Michael Dale, senior vice president of Abbott's structural heart business. "This approval strengthens our structural heart portfolio of minimally invasive offerings by providing new options and improvements to treat a life-threatening heart condition."
References
1 Mayo Clinic. Transcatheter aortic valve replacement (TAVR). August 2020.
2 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.
Aortic stenosis restricts blood flow through the aortic valve to the rest of the body, which can lead to heart failure and, in certain cases, sudden cardiac death.1 For some diagnosed with severe aortic stenosis, open-heart surgery is considered high-risk due to potential complications stemming from age, frailty, or having multiple other diseases or conditions.2 TAVI is a less invasive alternative to surgical aortic valve replacement.
"With an aging world population and with aortic stenosis cases projected to double in Europe and the U.S. in the next few decades, the need for innovative, minimally invasive solutions is critical," Lars Søndergaard, M.D., professor of Cardiology, Rigshospitalet, Copenhagen University Hospital in Denmark, who served as co-principal investigator for the global Navitor TAVI system clinical study, told the press. "While transcatheter valve replacement has for some time been a standard of care for patients with a narrowing of the aortic valve, Navitor helps to address challenges we sometimes find in current TAVI systems when we encounter complex patient anatomies that can lead to potential complications."
Navitor features a fabric cuff (NaviSeal) that works with the cardiac cycle to reduce or eliminate 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 received CE mark in 2020 and offers 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, enabling better valve placement and performance for patients so they can get back to living fuller, healthier lives," said Michael Dale, senior vice president of Abbott's structural heart business. "This approval strengthens our structural heart portfolio of minimally invasive offerings by providing new options and improvements to treat a life-threatening heart condition."
References
1 Mayo Clinic. Transcatheter aortic valve replacement (TAVR). August 2020.
2 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.
