With the approval, physicians implanting Portico can benefit from improved delivery, flexibility and navigation during implant, even in complex cardiac anatomies.
The new FlexNav delivery system demonstrates Abbott's commitment to developing new tools for doctors to treat patients requiring a transcatheter aortic valve implant. The approval and launch of the FlexNav delivery system follow first global implants in a clinical study of Abbott's next generation Navitor TAVI system, which were recently conducted at Rigshospitalet in
Transcatheter aortic valve replacement (TAVR) is a minimally invasive alternative to surgical aortic valve replacement for patients at high or extreme risk for open heart surgery who are diagnosed with severe aortic stenosis, a condition which restricts blood flow through the valve. While valve technology improvements have helped reduce adverse events and improve patient outcomes, improvements to delivery systems are critical to improving the placement and positioning of the valve. Based on physician feedback, Abbott developed the FlexNav delivery system to incorporate more stability, predictability and placement accuracy into the TAVI procedure.
'As a therapy, TAVR is now fairly mainstream and has helped countless patients around the world live better lives, but physicians have continued to seek improvements to how we deliver a valve to optimize outcomes for our patients,' said
Clinical experience with the FlexNav delivery system has yielded positive outcomes for patients to date. Data presented at the 31st annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in
'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,' said
The Portico Transcatheter Aortic Valve and FlexNav Delivery System are approved for investigational use only in the
The Navitor Transcatheter Aortic Valve is Abbott's next generation TAVI valve, currently under investigation in
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