FDA Approves a Second Device for Tricuspid Valve Repair

Pascal PrecisionWhat to know

30-second read

For Cardiology · Cardiothoracic Surgery

Who

Adults with symptomatic severe tricuspid regurgitation on optimal medical therapy, at intermediate or greater surgical risk, selected by a multidisciplinary heart team.

What it does

A catheter-delivered clip grasps and coapts the leaking tricuspid valve’s leaflets (T-TEER) to reduce regurgitant flow, without open-heart surgery.

Evidence

Approval rests on the randomized CLASP II TR pivotal trial (∼2:1 vs. medical therapy); 1-year results publish at TCT, Oct 31–Nov 3, 2026 — after this approval.

What’s different

The second FDA-approved T-TEER device after Abbott’s TriClip (2024), giving heart teams a device choice for the first time.

Key consideration

Pivotal efficacy and safety data were not yet public at approval. The single-arm CLASP TR feasibility study found 86% moderate-or-less TR at 1 year.

Availability

Approved Oct 21, 2026, on Edwards’ mitral-approved Pascal platform; TriClip-only programs will need second-device training and credentialing.

Practice impactConsider for selected patients

A genuine second T-TEER option for severe TR, but counsel patients using the smaller CLASP TR feasibility data until CLASP II TR’s randomized results publish at TCT.

Read the full physician analysis

Full analysis · 8 min readEdwards FDA approval release, 21 Oct 2026 · CLASP II TR (NCT04097145) · CMS NCD 20.38

FDA approved Edwards Lifesciences’ Pascal Precision system for transcatheter tricuspid edge-to-edge repair (T-TEER) on October 21, 2026. For two years, any structural heart program offering a catheter-based repair for a leaking tricuspid valve had exactly one approved device to offer: Abbott’s TriClip, cleared in April 2024. That changes now. What makes this approval unusual is the evidence sitting behind it — FDA cleared Pascal Precision on the strength of a pivotal randomized trial whose own one-year results will not be public until days after this story publishes, leaving physicians to counsel patients from an earlier, smaller feasibility study in the meantime.

Who actually meets the indication

FDA’s approved indication covers adults with symptomatic severe tricuspid regurgitation (TR) who remain symptomatic despite optimal medical therapy, who are at intermediate or greater risk for open tricuspid surgery, and whom a multidisciplinary heart team has judged anatomically suitable for T-TEER after echocardiographic assessment. That wording tracks closely with TriClip’s own indication, which is deliberate: FDA is applying the same patient-selection standard it set for the first T-TEER device to the second one, rather than carving out a narrower or broader population. Severe TR left untreated is associated with progressive right heart failure, hospitalization and reduced survival, which is why an intermediate-or-greater surgical risk threshold — not a surgical-ineligibility requirement — keeps a meaningful slice of patients in the referral pool rather than limiting the device to those with no surgical option left.

The evidence behind the approval, and what is still pending

This is the detail most coverage of the approval glossed over, and it matters for how a physician should talk to a patient about it right now. FDA’s review rested on the CLASP II TR pivotal trial (NCT04097145), a prospective, multicenter trial that randomizes patients roughly 2:1 to the Pascal system plus optimal medical therapy or to optimal medical therapy alone. Edwards has said the trial’s one-year clinical and health-status outcomes will be presented in a late-breaking session at TCT 2026 in San Diego, October 31 to November 3 — a presentation that falls after this approval. That means the primary efficacy and safety data FDA actually reviewed to clear the device is not yet in the public literature a physician can read or hand to a patient.

What is public is an earlier, separate study: the single-arm CLASP TR feasibility trial, presented at EuroPCR and ACC in 2022, which enrolled 65 patients with severe-to-torrential TR and reported one-year outcomes in the 46 with complete follow-up. All 46 achieved at least a one-grade reduction in TR severity, 75% achieved at least a two-grade reduction, and 86% reached moderate or less TR by one year, alongside improved NYHA functional class, quality-of-life scores and six-minute walk distance. It is reassuring early signal from the same device platform — but it is a 65-patient, uncontrolled feasibility study, not the randomized pivotal trial this approval is actually based on. Prescribing and counseling decisions made before TCT should say so explicitly.

Choosing between two clips

TriClip has a two-year head start and a published randomized trial behind it: TRILUMINATE Pivotal, which FDA reviewed for its April 2024 approval, randomized patients against medical therapy and reported that 90% of TriClip patients moved from severe-or-greater to moderate-or-less TR by 30 days, with a favorable composite outcome at one year. Pascal Precision cannot yet point to an equivalent published randomized result for tricuspid repair — that is precisely the data TCT 2026 will supply. The two devices also differ mechanically: Pascal’s paddle-and-clasp system captures each leaflet independently, where TriClip’s clip captures both together, a design difference a 2025 three-dimensional imaging study found produced similar acute tricuspid annular remodeling between the two devices despite the different mechanics. No randomized trial has compared the two devices head-to-head; device selection today comes down to anatomy, operator experience with a given platform, and which systems a given institution has credentialed, not a performance edge established in the literature.

Two FDA-approved T-TEER devices

	Abbott TriClip (approved Apr 2024)	Edwards Pascal Precision (approved Oct 2026)
Pivotal evidence	TRILUMINATE Pivotal (randomized vs. medical therapy), published	CLASP II TR (randomized vs. medical therapy), 1-year results pending at TCT 2026
Reported TR reduction	90% moderate-or-less TR by 30 days (TRILUMINATE)	86% moderate-or-less TR at 1 year in the smaller CLASP TR feasibility study
Leaflet-capture mechanism	Single clip captures both leaflets together	Independent paddle-and-clasp capture of each leaflet
Indication	Symptomatic severe TR on OMT, intermediate-or-greater surgical risk, heart-team judgment	Same framework: symptomatic severe TR on OMT, intermediate-or-greater surgical risk, heart-team judgment
CMS coverage pathway	NCD 20.38, CPT 0569T/0570T, coverage with evidence development	Same procedure-level NCD and CPT codes apply

Comparative figures come from each device's own published trial, not a head-to-head study; no randomized trial has directly compared TriClip and Pascal Precision for tricuspid repair. Select and counsel from current labeling and the primary trial reports, not this table.

Coverage was already settled before this approval

Physicians weighing whether a patient’s procedure will be paid for can start from a settled answer: CMS covers T-TEER nationally under National Coverage Determination 20.38, effective July 2, 2025 and implemented January 5, 2026, as coverage with evidence development (CED). Claims are billed under CPT 0569T for the initial prosthesis and 0570T for each additional prosthesis placed in the same session, alongside ICD-10-PCS code 02UJ3JZ and one of several qualifying principal diagnosis codes (including I07.1, I07.2, I08.1–I08.3, I36.1, I36.2 and Q22.8). That NCD is procedure-level, not device-specific — it does not name TriClip or Pascal Precision — so Pascal Precision’s FDA approval does not require a separate CMS coverage decision to be billable. The CED structure still matters operationally: CMS does not cover T-TEER for a patient treated outside a CMS-approved study, which in practice means the procedure stays tied to registry participation (such as the STS/ACC TVT Registry) regardless of which device a program uses.

What a heart team does differently

• Device selection, not device necessity. A program already offering TriClip is not obligated to add Pascal Precision; a program choosing its first T-TEER device now has two FDA-approved options to evaluate rather than one.
• Credentialing takes time. Standing up a second platform means procurement, operator training and institutional credentialing specific to Pascal Precision, even at a center that already runs a mature TriClip program.
• Counsel from the data that exists. Until CLASP II TR’s own results post at TCT, a physician recommending Pascal Precision today is reasoning from CLASP TR’s smaller feasibility results and FDA’s own (not yet public) review of the pivotal data — say so to the patient, not just to colleagues.
• Referral and registry logistics are unchanged. Patient identification, heart-team evaluation and TVT Registry enrollment work the same way regardless of which approved device a program ultimately selects.

What happens at TCT

The near-term event that actually changes what physicians know is not this approval but the conference four days after it. When CLASP II TR’s one-year results are presented at TCT 2026, they will supply the randomized comparator data this approval was reviewed against but has not yet shown the public — the primary efficacy composite, the safety profile across the full pivotal cohort, and responder-rate definitions that the smaller CLASP TR study cannot provide. Until then, Pascal Precision’s own instructions for use and FDA’s approval order, not secondary coverage including this one, govern precise patient-selection and monitoring decisions.

Frequently asked questions

Can a heart team use Pascal Precision for a tricuspid patient today, or is this approval conditional on more data?

The approval is unconditional and the device is approved for use now. What is still pending is the public release of CLASP II TR's own one-year randomized results, scheduled for presentation at TCT 2026 (October 31–November 3). FDA reviewed that data to approve the device; physicians and patients weighing the evidence today only have the earlier, smaller CLASP TR feasibility results publicly available.

Does a program that already offers TriClip need to switch to Pascal Precision, or can it offer both?

Nothing requires a switch. Pascal Precision is a second option, not a replacement — Abbott's TriClip remains FDA-approved and on the market. A program can continue offering TriClip alone, add Pascal Precision alongside it, or select based on anatomy, operator experience and institutional contracting, the same way many mitral TEER programs already carry more than one device.

Is a patient's tricuspid repair procedure covered by Medicare now that a second device is approved?

Coverage was already established before this approval. CMS covers T-TEER nationally under National Coverage Determination 20.38 (effective July 2, 2025) as coverage with evidence development, billed under CPT codes 0569T and 0570T. That procedure-level coverage applies to any FDA-approved T-TEER device used at a site participating in a CMS-approved study, Pascal Precision included — it does not require a device-specific coverage decision.