Portico TAVR system gains FDA approval for very high-risk patients
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Abbott announced the FDA has approved its minimally invasive transcatheter aortic valve replacement system for patients with severe symptomatic aortic stenosis at high or extreme risk for open-heart surgery.
According to a company press release, the self-expanding TAVR valve (Portico) is implanted using Abbott’s newly approved delivery system (FlexNav), which features a slim design to accommodate different patient anatomies and small vessels and improves ease of tracking and precision of valve placement.
"With the approval of our TAVR therapy in the U.S., physicians now have access to an even more robust set of solutions to treat structural heart disease," Michael Dale, senior vice President of Abbott's structural heart business, said in the release. "This latest and important introduction of Portico with FlexNav represents another milestone in our work to advance our mission to restore health and improve quality of life so more people can get back to living fuller lives."
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