Abbott receives CE mark for FlexNav delivery system

Portico TAVI system
Portico TAVI system

Abbott has received CE mark in Europe for the new FlexNav delivery system for the company’s Portico transcatheter aortic valve implantation (TAVI) system. A statement from the company says that with the approval, physicians implanting Portico can benefit from improved delivery, flexibility and navigation during implant, even in complex cardiac anatomies.

The press release states that clinical experience with the FlexNav delivery system has yielded positive outcomes for patients to date. Data presented at the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in September 2019 showed that within the Portico U.S. IDE Study, patients who received a Portico valve implanted with the FlexNav Delivery System saw no deaths, no strokes and low rates of major vascular complications and new permanent pacemaker implants after 30 days.

Abbott says the new FlexNav delivery system demonstrates its commitment to developing new tools for doctors to treat patients requiring TAVI. 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, recently conducted by a clinical team led by Lars Sǿndegaard, (Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark). Sǿndegaard also serves as coprincipal investigator for the trial.

Based on physician feedback, says Abbott, it developed the FlexNav delivery system to incorporate more stability, predictability and placement accuracy into the TAVI procedure.

“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,” says Neil Moat, chief medical officer of Abbott’s structural heart business. “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.”


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