Watch leading implanters discuss tricuspid leaflet repair therapy

Video Highlights


Uniqueness of tricuspid regurgitation
History of Edwards Lifesciences
PASCAL repair system in
tricuspid valve
PASCAL Ace implant
Why tricuspid therapy?

An innovative system designed to address the complexity of tricuspid repair

Effectively bridges the coaptation gap while optimising leaflet capture

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
Specifically designed to reduce stress on fragile leaflets

Central spacer effectively bridges the coaptation gap

  • Broad, contoured paddles increase coaptation area
  • Spacer reduces leaflet stress and increases open orifice area
Approach your procedure with confidence

Safely navigate your procedure within the
subvalvular apparatus

  • Implant elongation facilitates safe repositioning in dense tricuspid chordae
  • Independent catheters allow for predictable implant positioning
Click to get the PASCAL Repair System for TR Brochure

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.
View Figures

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.

CLASP TR Early Feasibility Study Clinical Summary

CLASP TR Early Feasibility Study Clinical Summary
Video Resources

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References
  1. 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).
  2. 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.
  3. Kodali S.,et al. Feasibility Study of the Transcatheter Valve Repair System for Severe Tricuspid Regurgitation JACC 2021;77(4):345-356.

For professional use

For professional use

For professional use. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use (consult eifu.edwards.com where applicable).

Edwards devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity.

Edwards, Edwards Lifesciences, the stylized E logo, Cardioband, PASCAL, PASCAL Ace, Valtech, and Valtech Cardio are trademarks or service marks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.

© 2020 Edwards Lifesciences Corporation. All rights reserved. PP—EU-0408 v3.0

Edwards Lifesciences • Route de l’Etraz 70, 1260 Nyon, Switzerland • edwards.com

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