The Abbott Park, Ill.-based company’s FlexNav delivery system is designed to offer another tool for doctors to treat patients requiring a transcatheter aortic valve implant by incorporating stability, predictability and placement accuracy in the procedure.
Abbott said in a news release that the approval and launch of the FlexNav delivery system follows the first global implants in a clinical study of its next-generation Navitor TAVI system.
Clinical study data presented in September 2019 revealed that in a Portico U.S. trial, patients who received a Portico valve implanted with FlexNav experienced zero deaths, zero strokes and low rates of major vascular complications and new permanent pacemaker implants after 30 days.
IRCCS Policlinico San Donato (Italy) head of cardiology Dr. Francesco Bedogni, a principal investigator in the U.S. study of FlexNav, said in the release that Abbott’s new delivery system can improve the implant process even in complex cardiac anatomies.
“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,” Abbott structural heart business chief medical officer Dr. Neil Moat said. “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.”
Portico and FlexNav are only approved for investigational use in the U.S., as is the Navitor TAVI system, according to the news release.