An innovative system designed to address the complexity of tricuspid repair
Independent grasping for optimal placement while
respecting native anatomy
- Atraumatic clasps with a single row of retention elements designed for fragile leaflets
- Staged capture and capture optimization facilitate maximum leaflet insertion
Central spacer effectively bridges the coaptation gap
- Broad, contoured paddles increase coaptation area
- Spacer reduces leaflet stress and increases open orifice area
Safely navigate your procedure within the
subvalvular apparatus
- Implant elongation facilitates safe repositioning in dense tricuspid chordae
- Independent catheters allow for predictable implant positioning
The PASCAL repair system showed promising in First-in-Human experience1,2,*
In early compassionate use experience, the PASCAL repair system demonstrated high procedural success, significant clinical improvements, and sustainable TR reduction in patients with challenging tricuspid anatomy and severe TR. In addition, favorable right ventricular remolding was observed at the 30-days follow-up.
Acute
Procedural Success
86%
Independent
Grasping Used
90%
Mortality at
30-days
7.1%
Residual TR≤2+
6 months
89%
*Site reported TR severity – no Echo Core Lab analyses
THE CLASP TR Early Feasibility Study3
30 days outcomes from the prospective, multicenter, single-arm study of the PASCAL transcatheter valve repair system in the treatment of patients with symptomatic TR
Methods
- Multicenter, prospective, single-arm study in the United States
- 34 patients underwent transcatheter tricuspid repair therapy with an Edwards PASCAL valve repair system
- Mean age 76 years
- NYHA Class III/IV: 79%
- TR severity ≥ severe (3+ grade): 97%
- Atrial fibrillation/flutter: 88%
Results
At 30 days:
- PASCAL shows a favorable safety profile and performed as intended in patients with symptomatic tricuspid regurgitation.
- Despite 55% torrential TR at baseline, importantly, 85% had at least 1 TR grade reduction and 70% patients had at least 2 TR grade reduction.
- The major adverse event rate was low at 5.9%, with no mortality, stroke, myocardial infarction, or reintervention.
- Patients experienced significant improvements in functional status, quality of life, and exercise capacity.
Figures: CLASP TR EFS
Conclusions
- In this early experience, the repair system performed as intended, with substantial TR reduction, favorable safety results with a low MAE rate, no mortality or reintervention, and significant improvements in functional status, exercise capacity, and quality of life.
For a more detailed overview of the CLASP TR EFS, please download the clinical summary.
TMTT Portfolio
Learn more about Edwards' transcatheter mitral
and tricuspid portfolio
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References
- Fam NP et al. Compassionate Use of the PASCAL Transcatheter Valve Repair System for Severe Tricuspid Regurgitation: A Multicenter, Observational, First-in-Human Experience. J Am Coll Cardiol. 2019;12(24).
- Lurz P et al. Six-month results of the PASCAL transcatheter valve repair system for severe tricuspid regurgitation: a multicentre, observational, first-in-human experience. PCR e-course 2020. 2020 June. Euro20A-POS487.
- Kodali S.,et al. Feasibility Study of the Transcatheter Valve Repair System for Severe Tricuspid Regurgitation JACC 2021;77(4):345-356.
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