FDA NewsPerspective

Next-generation balloon-expandable TAVR valve receives FDA approval

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.”

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.
Source: Adobe Stock

“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.

Disclosure: Webb reports he is a consultant for Edwards Lifesciences. Wood is an employee of Edwards Lifesciences.

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.”

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.
Source: Adobe Stock

“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.

Disclosure: Webb reports he is a consultant for Edwards Lifesciences. Wood is an employee of Edwards Lifesciences.

    Perspective
    Dean J. Kereiakes

    Dean J. Kereiakes

    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.

    • Dean J. Kereiakes, MD, FACC, FSCAI
    • Cardiology Today’s Intervention Editorial Board Member
      The Christ Hospital Lindner Research Center
      Ohio State University

    Disclosures: Kereiakes reports he received personal fees for consulting from Abbott Vascular, Boston Scientific, Caliber Therapeutics/Orchestra BioMed, Micell Technologies, Sino Medical Sciences Technologies and Svelte Medical Systems, and he is a major stock shareholder of Ablative Solutions. He has no financial ties to Edwards Lifesciences.