Data Readout

Edwards' RESILIA tissue posts 97.9% freedom from valve deterioration at 10 years

The COMMENCE trial's decade-long follow-up gives Edwards Lifesciences durability data on its RESILIA-treated pericardial valves, a bar every next-generation tissue platform in aortic and mitral replacement will be measured against.

By AppliedXLJuly 13, 2026Trial NCT01757665

Executive Summary

Edwards Lifesciences' decade-long COMMENCE trial shows its RESILIA-treated pericardial bioprostheses hold up structurally at 10 years, extending the durability record behind a tissue platform the company has built much of its surgical and transcatheter valve business around.
The event marks the trial's actual data disclosure rather than a still-pending readout, closing out a study that ran more than a decade past its original completion target.
No other sponsor in the aortic or mitral valve landscape runs a directly comparable anti-calcification tissue treatment, so the finding reinforces RESILIA's position rather than testing it against a named rival platform.
The result feeds directly into how surgeons and guideline committees weigh valve choice and reintervention timing as Edwards expands RESILIA across its SAPIEN and surgical lines.

The result

COMMENCE (NCT01757665) enrolled 777 patients across the United States, Canada and Poland to evaluate Edwards Pericardial Bioprostheses built on the RESILIA tissue platform. At the 106th American Association for Thoracic Surgery Annual Meeting, Edwards reported that at 10 years, 97.9% of patients remained free from structural valve deterioration (SVD), 97.8% were free from reoperation due to SVD, and 98.6% were free from non-structural valve dysfunction, with gradients and effective orifice area sustained over the follow-up period. The trial's registered primary endpoint tracked the rate of implanted subjects experiencing SVD by the post-operative day 390 follow-up visit, and the posted ClinicalTrials.gov results confirm SVD as the primary outcome measure. NCT01757665

How it was run

COMMENCE is a prospective, non-randomized, multicenter study, run across 32 facilities, that began enrolling in December 2012 and reached its actual target of 777 patients. The registry lists the trial's primary completion date as August 2017, with the study only moving to Completed status in May 2026, nearly nine years later, as long-term follow-up matured. Safety reporting through three years post-implant for the aortic cohort and four years for the mitral cohort recorded serious adverse events including paroxysmal atrial fibrillation, third-degree AV block and persistent atrial fibrillation, drawn from the posted adverse-event tables. NCT01757665

Context: the sponsor's framing

Edwards told investors in December 2025 that "Surgical performance driving RESILIA innovations to transform patients' lives globally" ranked among its priorities entering 2026, alongside guidance for surgical sales of $1.05 billion to $1.13 billion for the year. The COMMENCE 10-year data give that framing a specific evidentiary anchor: a decade of freedom-from-deterioration results across a study population large enough to support durability claims for the material across Edwards' broader valve lines, including SAPIEN 3 Ultra RESILIA. Edwards

Competitive frame

The aortic and mitral valve landscape includes device platforms from Medtronic, Abbott, Pi-cardia and Foldax, along with pharmacologic comparators such as edoxaban and pelacarsen studied in adjacent aortic-stenosis trials, but none of the named competitors in this landscape shares RESILIA's anti-calcification tissue treatment. That leaves the 10-year durability data without a same-platform benchmark to weigh against; the closest comparators are other Edwards valve programs, including the SAPIEN 3/SAPIEN 3 Ultra and SAPIEN X4 transcatheter platforms, and rival mechanical or tissue valve programs that test different materials entirely.

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.