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May 18, 2020

Edwards Pascal System Approved in Europe for Tricuspid Repair

May 18, 2020—Edwards Lifesciences Corporation announced that it has received European CE Mark approval for the Pascal transcatheter valve repair system for the treatment of patients with tricuspid regurgitation (TR).

According to the company, the Pascal system is indicated in Europe for the percutaneous reconstruction of the tricuspid valve through leaflet repair by tissue approximation. The device is not approved in the United States.

“Although the prevalence of tricuspid valve disease and the associated mortality are high, there are limited effective treatment options for these very symptomatic patients, who often cannot have surgery due to the prohibitive risk,” commented Professor Jörg Hausleiter, MD, in the company’s announcement. He continued, “Transcatheter tricuspid therapy can be challenging due to the fragile leaflets and the large defects during valve closure. In our experience, the Pascal system’s independent grasping ability as well as the flexible and less traumatic clasp design are important features for our patients.” Prof. Hausleiter is from Medizinische Klinik der Ludwig-Maximilians-Universität München in Munich, Germany.

According to the company, early clinical experience with the Pascal repair system has 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.

Edwards stated that with the launch of the Pascal system for the treatment of TR patients in Europe, it is focused on procedural success and differentiated patient outcomes, with a high-touch clinical support model. Additionally, Edwards’s CLASP II TR pivotal study is investigating the Pascal system in patients with symptomatic functional or degenerative TR. The company’s Evoque system for tricuspid valve replacement is being evaluated in the TRISCEND study, as well as in real-world experience.

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