New
Enabling Safe and Effective Reduction of Tricuspid Regurgitation (TR)​

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.

Tricuspid Leaflet Repair Therapy

An innovative system designed to make leaflet repair a reality for patients with
tricuspid regurgitation

Effectively bridges the coaptation gap while optimising leaflet capture

Effectively bridges the coaptation gap while optimising leaflet capture

  • Central spacer fills the gap
  • Independent grasping
Specifically designed to reduce stress on fragile leaflets

Designed to reduce stress on fragile leaflets

  • Broad, contoured paddles
  • Atraumatic clasps with a single row of retention elements
Approach your procedure with confidence

Approach your procedure with confidence

  • Implant elongation facilitates safe repositioning within the subvalvular apparatus
  • Independent catheters allow for precise navigation

Click to download PDF

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

In early compassionate use exprience, the PASCAL repair system demonstrated high procedural success and significant clinical improvements in patients with challenging tricuspid anatomy and severe TR. In addition, favorable right ventricular remodling was observed at the 30-days follow-up.

Acute
Procedural Success

86%

Independent
Grasping Used

90%

Mortality at
30 days

7.1%

Acute Efficacy
(TR ≤2+)

85%

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

Watch the PASCAL repair system procedural animation

PASCAL repair system procedural animation

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Learn more about Edwards' transcatheter mitral and tricuspid portfolio

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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).

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 v1.0

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

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