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Next-generation Balloon-expandable TAVR Valve Receives FDA Approval
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Edwards Lifesciences announced its next-generation balloon-expandable valve has received approval from the FDA for transcatheter aortic valve replacement in patients with severe, symptomatic aortic stenosis at intermediate or greater risk for open-heart surgery.
As Cardiology Today’s Intervention previously reported, the next generation balloon-expandable valve (Sapien 3 Ultra) previously received clearance for use in Europe in November.
“The advanced Sapien 3 Ultra system features enhancements on the valve and a new delivery system to address the needs of both patients and clinicians, building on our best-in-class performance of Sapien 3 to further advance and improve patient care,” Larry L. Wood, Edwards’ corporate vice president, transcatheter heart valves, said in a press release. “We look forward to introducing the Sapien 3 Ultra system to U.S. patients.”
“The Edwards Sapien 3 Ultra system provides meaningful technology improvements that help further optimize the transcatheter aortic valve replacement procedure, adding simplicity and advancing patient care,” John G. Webb, MD, director of interventional cardiology and cardiac catheterization laboratories at St. Paul’s Hospital, in Vancouver, and professor of cardiology at the University of British Columbia, said in the release. – by Earl Holland Jr.
Disclosures: Webb reports he is a consultant for Edwards Lifesciences. Wood is an employee of Edwards Lifesciences.
Perspective
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Dean J. Kereiakes, MD, FACC, FSCAI
The new balloon-expandable valve is an excellent one and appears to be more user-friendly than the previous version. We like having the ability to choose specific TAVR valves for specific patients. We often use the Edwards valves in cases with baseline conduction abnormalities such as bifascicular block because the balloon-expandable valves have a lower rate of high-degree AV block compared with either the self-expanding valves (Corevalve family of products, Medtronic) or the mechanically expanding valves (Lotus, Boston Scientific).
In a separate case with significant nodular calcium in the outflow tract, if we had used a balloon-expandable valve, we could have pushed the calcium nodule through the outflow tract. We picked the Lotus Edge for that case because of its gradual expansion with high radial strength, superior sealing properties to reduce paravalvular leak and exquisite repositionable capabilities which allow placement of the valve perfectly without annular or outflow tract rupture.
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