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March 5, 2020

Abbott Receives CE Mark Approval of FlexNav Delivery System for Portico Valve

March 5, 2020—Abbott announced it has received CE Mark approval for the FlexNav delivery system, which is used with the company’s Portico transcatheter aortic valve replacement (TAVR) system. The company stated that the new FlexNav provides improved delivery, flexibility, and navigation during implantation of the Portico, even in complex cardiac anatomies.

The approval and launch of the FlexNav delivery system come after the first global implants in a clinical study of Abbott’s next-generation Navitor TAVR system, which was recently conducted at Rigshospitalet in Copenhagen, Denmark. The procedures were performed by Lars Sǿndegaard, MD, Professor of Cardiology at Rigshospitalet, Copenhagen University Hospital. Prof. Sǿndegaard serves as the trial’s Coprincipal Investigator.

Interventional cardiologist Francesco Bedogni, MD, commented in Abbott’s announcement, “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. With Abbott’s new FlexNav delivery system, the company has introduced a delivery system that improves the implant process even in incredibly complex cardiac anatomies.” Dr. Bedogni, who is Head of Cardiology at the IRCCS Policlinico San Donato in Italy, served as Principal Investigator of the FlexNav substudy within the Portico global investigational device exemption (IDE) trial.

Abbott noted that clinical experience with the FlexNav delivery system has yielded positive outcomes for patients, including data from the United States Portico IDE study that were presented in September at TCT 2019, the 31st annual Transcatheter Cardiovascular Therapeutics scientific symposium. The study showed that patients who received a Portico valve implanted with the FlexNav delivery system experienced no deaths, no strokes, and low rates of major vascular complications and new permanent pacemaker implants after 30 days.

The company advised that the Portico TAVR device and FlexNav delivery system are approved for investigational use only in the United States. Abbott’s next-generation Navitor TAVR system is currently under investigation in the United States. The Navitor valve is approved only for investigational use.

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