Abbott has received CE mark to market its new transcatheter aortic valve implantation (TAVI) system, Navitor, in Europe to treat severe aortic stenosis patients with high or extreme surgical risk.
A minimally invasive device, Navitor has a fabric cuff called NaviSeal that acts with the cardiac cycle to lower or prevent paravalvular leak (PVL).
PVL is a complication that results from TAVI procedures and causes blood backflow around the valve frame.
The latest device is a self-expanding TAVI system with intra-annular leaflets and large frame cells. It could offer access to vital coronary arteries to aid procedures for coronary artery disease treatment in the future.
In addition, the system’s design offers enhanced haemodynamics or improved blood flow, Abbott said.
Implanted using Abbott’s CE marked FlexNav delivery system, Navitor comes with a slim design and the minimal TAVI delivery system profile to treat patients with vessels as small as 5mm.
Furthermore, the catheter fits various aortic anatomies for steady, predictable and precise delivery and placement of the valve.
Abbott structural heart business senior vice-president Michael Dale said: “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.
“This approval strengthens our structural heart portfolio of minimally invasive offerings by providing new options and improvements to treat a life-threatening heart condition.”
Along with the Navitor valve, Abbott is developing additional TAVI therapies such as a design to stop blood leakage near the aortic valve.
Aortic stenosis hinders blood flow via the aortic heart valve to other body parts, which can cause heart failure and even sudden cardiac death in some cases.
Last month, Abbott received CE mark for the use of its Panbio COVID-19 Ag Rapid Test Device to detect the SARS-COV-2 virus in paediatric patients aged 15 years and below.