Tricuspid Regurgitation (TR) is Largely Untreated Despite High Mortality Rates

Monitor images of heart

Patients with tricuspid regurgitation (TR) are rarely surgically treated1, are medically managed, and often experience debilitating symptoms. While the prevalence of TR and the associated mortality rates for severe TR are high2,3, limited treatment options exist.

The Edwards PASCAL transcatheter valve repair system adds to TMTT’s portfolio of TR treatment options and is designed to treat both mitral and tricuspid regurgitation, improving patient symptoms and quality of life using the same device.

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

The PASCAL repair system shown promising in First-in-Human experience4,5,*

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%

Acute (TR ≤2+)
6 months

89%

*Site reported TR severity – no Echo Core Lab analyses
Procedure Animation

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PASCAL repair system procedural animation

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References
  1. Fender EA, Zack CJ, Nishimura RA. Isolated Tricuspid Regurgitation: Outcomes and Therapeutic Interventions. Heart 2018;104:798–806.
  2. Topilsky Y et al. Burden of Tricuspid Regurgitation in Patients Diagnosed in the Community Setting. JACC Cardiovasc Imaging 2018 Aug 6. Epub 2018 Aug 6
  3. Nath J, Foster E, Heidenreich PA. Impact of tricuspid regurgitation on long-term survival. J Am Coll Cardiol. 2004;43:405-409.
  4. 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).
  5. 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.

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, 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 v2.0

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

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