Abbott’s FlexNav Cleared in EU to Deliver Portico Transcatheter Aortic Valve

Abbott announced that it received the EU CE Mark for the new FlexNav delivery system for the company’s Portico transcatheter aortic valve.

Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure for patients diagnosed with aortic stenosis, a condition which restricts blood flow through the valve. TAVR is particularly important as an alternative to open heart surgery for patients at high risk who may not be candidates for open heart surgery.

The FlexNav delivery system gives physicians more stability, predictability and placement accuracy during the TAVI procedure. While valve technology improvements have helped reduce adverse events and lead to better patient outcomes, advancements to delivery systems are critical to improving the placement and positioning of the valve, according to the announcement.

“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 Neil Moat, M.D., chief medical officer of Abbott’s structural heart business, in the release. “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.”