Cardiology CE Mark Structural Heart

Edwards Makes Gains in Tricuspid Regurgitation Repair with CE Mark

The Irvine, CA-based company said the Pascal repair system demonstrated high procedural success and significant clinical improvements in patients with challenging tricuspid anatomy and severe TR. Sustained TR reduction was observed at 30 days, with 85% of patients seeing a reduction to TR ≤2+ on a five-grade scale.

“Patients with tricuspid valve disease are in great need of solutions,” said Bernard J. Zovighian, Edwards’ corporate vice president, transcatheter mitral and tricuspid therapies. “Edwards is the first company to introduce multiple transfemoral tricuspid repair therapies in Europe, providing physicians with both leaflet repair and annular reduction therapies to help meet their patients’ needs.”

Edwards hasn’t secured FDA approval for Pascal.

There have been some developments in the tricuspid mitral valve space. Earlier this year, Cardiovalve obtained breakthrough device designation and FDA approval of a feasibility study for its transcatheter tricuspid valve replacement system.

Cardiovalve was originally a part of Valtech Cardio, a company acquired by Edwards Lifesciences for $340 million and up to $350 million in milestone payments.

Abbott Laboratories launched a pivotal trial in September of last year for the Triclip TR treatment system. The study enrolled 700 patients and is set to follow them for five years.


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