Abbott has secured CE Mark for the FlexNav delivery system intended for its Portico transcatheter aortic valve implantation (TAVI) system.
The approval, which follows a clinical study of Abbott’s Navitor TAVI system, will enable the marketing authorisation of FlexNav in Europe.
The system is intended for patients who require transcatheter aortic valve implants, providing physicians implanting Portico with improved delivery, flexibility and navigation.
FlexNav, developed by the company based on feedback from the physicians, is designed to incorporate increased predictability stability and placement accuracy into the TAVI procedure.
The company notes that transcatheter aortic valve replacement (TAVR) is a minimally invasive alternative to surgical aortic valve replacement for patients with severe aortic stenosis. The condition places high or extreme risk for open-heart surgery in patients by restricting blood flow through the valve.
Improvements in valve technology are said to have reduced adverse events and increase patient outcomes. However, changes to delivery systems are deemed vital in enhancing the placement and positioning of the valve.
Abbott claims that its FlexNav delivery system has provided positive outcomes for patients in the clinical study.
According to the company, no deaths or strokes took place in patients who received a Portico valve implanted with the FlexNav delivery system. Furthermore, researchers observed low rates of major vascular complications in patients, with new permanent pacemaker implants fitted after 30 days.
Abbott structural heart business chief medical officer Neil Moat said: “Within the field of TAVI, delivery systems often don’t receive the attention of the evolving technology of the valves themselves, but improvements to a delivery system can result in substantial benefits to patients.
“If we look at the total TAVI procedure, innovation around both the valve itself and also how it’s delivered during an implant are both central to improving outcomes.”
The company received approval for its Gallant ICD and CRT-D devices in Europe last month.