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Edwards Lifesciences has also presented semi-annual TRISCEND II data from the first 150 patients that successfully demonstrate the safety and efficacy of the EVOQUE system, with improvements in patients' quality of life and functional outcomes.

Edwards Lifesciences has announced that the company's EVOQUE tricuspid valve replacement system has received CE mark for the transcatheter treatment of eligible patients with tricuspid regurgitation (TR). The EVOQUE system is the world's first transcatheter valve replacement therapy to receive regulatory approval to treat TR. Patients who have diseases related to the tricuspid valve suffer greatly, and can have symptoms ranging from debilitating to fatal, with few options to alleviate them.

"It is excellent news to have new therapeutic options in the treatment of tricuspid insufficiency. The Evoque system is a percutaneous prosthesis that will offer a new therapeutic alternative in these patients" says Professor Zamorano, Head of Cardiology, Ramón y Cajal University Hospital. (Madrid).

"The clinical trials carried out offer very promising data on both safety and efficacy, with a significant improvement in the quality of life of these patients."

During the 35th edition of the Transcatheter Cardiovascular Therapeutics (TCT), the company presented the satisfactory results of TRISCEND II, a pivotal randomized controlled trial designed to evaluate the safety and effectiveness of the innovative EVOQUE tricuspid valve replacement system together with optimal medical treatment (BMT) compared to BMT alone, with 2:1 randomization.

Results from the first 150 patients in the TRISCEND II trial met the primary safety endpoint at 30 days and the two co-primary efficacy endpoints at six months, demonstrating its superiority over BMT. Optimal) alone. EVOQUE also achieved substantially better quality of life results at six months.

Patients included in the TRISCEND II trial had at least one severe tricuspid regurgitation. The EVOQUE valve was successfully implanted in 95.8% of patients and the trial met all primary endpoints with:

• Rate of serious adverse events of 27.4% at 30 days,

• Significant reduction in the degree of TR, with 98.8% of patients with TR ≤ moderate and 93.8% with TR ≤ mild at six months,

• Significantly superior functional and quality of life outcomes at six months for the composite endpoint including KCCQ, NYHA, and 6MWD for the EVOQUE system plus TMO over TMO alone.

"Patients suffering from severe tricuspid regurgitation suffer debilitating symptoms and have a poor quality of life. They are desperate to receive effective treatment, as demonstrated by the rapid participation in this trial" says Ramón García Furquet, Country Director of Edwards Lifesciences in Spain. "These data build on the encouraging foundation of published results from the single-arm TRISCEND study, adding to the growing body of clinical evidence, allowing more patients to receive the treatment they need."

The EVOQUE system is comprised of a self-expanding nitinol frame, an intra-annular sealing skirt, and a tissue prosthesis made from the same bovine pericardium tissue as the company's market-leading heart valves. The EVOQUE valve will be available in three sizes, all of which can be implanted through a low-profile 28F transfemoral system.

Contact

Contact name: Havas PR

Contact description: Havas PR

Contact telephone number: 914 56 90 00

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Caption: Logo Edwards Lifesciences Author: Havas PR