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FDA gives green light for Edwards' SAPIEN 3 Ultra system

por John R. Fischer, Senior Reporter | January 02, 2019
Cardiology Operating Room
SAPIEN 3 Ultra System
Edwards Lifesciences Corporation has been given a green light from the FDA to initiate sales of its SAPIEN 3 Ultra system.

Designed for transcatheter aortic valve replacement, the solution stands as an alternative to patients with severe symptomatic aortic stenosis who face intermediate or greater risks from open-heart surgery.

"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 of transcatheter heart valves, said in a statement. "We look forward to introducing the SAPIEN 3 Ultra system to U.S. patients."

Created with an “on balloon” design, the valve requires no aligning during procedures and does not incur the risk of paracalvular leaks due to its heightened outer skirt. It also comprises a low-profile 14-French Axela expandable sheath and comes in three sizes: 20, 23 and 26 mm.

The system was cleared and introduced this November in Europe, as part of a controlled rollout that includes training to ensure high procedural success of the advanced valve and delivery system. It was not, however, released in Germany, due to a preliminary injunction brought forth by Boston Scientific on its future sales and use back in October, with the courts there upholding the ruling.

A U.S. jury recently awarded $35 million in damages to Boston Scientific for infringement by Edwards of a patent for a transcatheter heart valve sealing skirt. Edwards does not expect to pay the award due to a determination earlier this year by the U.S. Patent and Trademark office that all asserted claims of the specific patent were invalid. It also plans to appeal a decision by the jury that found Edwards' foundational U.S. Spenser Patents for transcatheter heart valves to be valid but not infringed on by Boston Scientific’s Lotus valve.

Having previously gained clearance for aortic and mitral valve-in-valve procedures, the solution has shown its worth not just in terms of care but as a cost-saving alternative to surgery. A recent trial found that use of the SAPIEN 3 valve saved patients nearly $16,000 in total one-year costs, on average, compared to surgical aortic valve replacement. Average index hospitalization costs, which include the price of the procedure, hospital stay and physician fees, were also lower.

"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 Webb, director of interventional cardiology and cardiac catheterization laboratories at St. Paul's Hospital in Vancouver, and a professor of cardiology at the University of British Columbia, said in a statement.

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