FDA Approves Edwards' Pascal Precision for Tricuspid Valve Repair

FDA approved Edwards Lifesciences' Pascal Precision system for transcatheter tricuspid valve repair on 21 October 2026, giving US heart teams a second approved device for tricuspid edge-to-edge repair (T-TEER) alongside Abbott's TriClip. The same action cleared a related mitral device, the Pascal Ace with Capture Clarity system, rounding out what Edwards says is the only US portfolio spanning repair and replacement transcatheter therapies for both the mitral and tricuspid valves.

What the approval covers

The Pascal Precision system is a catheter-delivered clip used to repair a leaking tricuspid valve without open-heart surgery — a procedure known as transcatheter tricuspid edge-to-edge repair, or T-TEER. FDA's approved indication covers patients with symptomatic severe tricuspid regurgitation (TR) who remain symptomatic despite optimal medical therapy, who are at intermediate or greater risk for open surgical repair or replacement, and whom a multidisciplinary heart team has judged appropriate for T-TEER based on an echocardiographic assessment of the valve's anatomy. The device builds on the Pascal platform's existing 2022 approval for degenerative mitral regurgitation, extending the same clip-based repair mechanism to the tricuspid valve.

A second option, not a first

Pascal Precision is not the first T-TEER device FDA has approved — Abbott's TriClip reached the US market first — but it is the first direct competitor, which changes the calculus for hospitals and heart teams that have so far had only one approved option for a condition that, left untreated, is associated with right heart failure, hospitalization and reduced survival. Having two approved systems typically brings device-selection criteria, site credentialing requirements for a second platform, and comparative long-term data into sharper focus for structural heart programs that will now need to choose, or offer both.

The evidence, and what is still pending

FDA's approval rests on the CLASP II TR pivotal trial, a prospective, multicenter, randomized trial that assigned patients in roughly a 2:1 ratio to the Pascal system plus optimal medical therapy or to optimal medical therapy alone. Edwards has said one-year results from that pivotal trial will be presented at the TCT 2026 conference in San Diego — a presentation that falls after this approval, meaning the detailed efficacy and safety data clinicians will use to counsel patients is not yet public. An earlier, smaller early feasibility study of the Pascal system in tricuspid repair (CLASP TR, not the pivotal CLASP II TR trial) reported at EuroPCR 2022 that 86% of patients with one-year follow-up had moderate or less TR, with Kaplan-Meier estimates of 87.9% freedom from all-cause mortality and 78.5% freedom from heart failure hospitalization at one year; that early study supported feasibility, not this approval's primary evidence base.

What this changes operationally

• Device selection and credentialing: structural heart programs now choosing between two approved T-TEER systems should expect procurement, training and credentialing processes to take time, particularly at centers that have standardized on a single platform since TriClip's approval.
• Evidence timing: because CLASP II TR's one-year results post-date the approval, clinicians and payers evaluating the device for individual patients or coverage policies will be working from FDA's review of the submitted data before the pivotal trial's full results are public at TCT 2026.
• Portfolio strategy: Edwards now has FDA-approved repair and replacement options for both the mitral and tricuspid valves, a combination the company says no competitor currently matches in the US — relevant for hospitals consolidating structural heart purchasing around fewer vendors.
• Risk stratification: the approved indication's reliance on “intermediate or greater surgical risk” and multidisciplinary heart team judgment means patient selection, not just device availability, remains the operative constraint on how quickly use expands.

What is not yet settled

The full CLASP II TR pivotal trial results — the primary safety and effectiveness endpoints FDA reviewed to reach this approval — have not yet been presented publicly; Edwards has said that will happen at TCT 2026. Until then, the complete adverse-event profile, the trial's precise responder-rate definitions, and any FDA-mandated post-approval study requirements belong in FDA's approval order and the device's instructions for use, not in secondary summaries.

Frequently asked questions

What did FDA approve, and when?

On 21 October 2026, FDA approved Edwards Lifesciences' Pascal Precision system for transcatheter tricuspid edge-to-edge repair (T-TEER).

Who is the device for?

Patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy, at intermediate or greater surgical risk, judged suitable for T-TEER by a multidisciplinary heart team.

What evidence supports it?

The CLASP II TR pivotal trial, a randomized comparison of the Pascal system plus medical therapy against medical therapy alone; one-year results are scheduled for TCT 2026, after this approval.

How does this change the market?

It is the second FDA-approved T-TEER device after Abbott's TriClip. The same action also cleared Edwards' Pascal Ace with Capture Clarity for mitral TEER, giving Edwards a full US repair-and-replacement portfolio across both valves.