PASCAL implant PASCAL implant

animated clasps

PASCAL Platform

One platform, two clasps in your hands

Now with the PASCAL repair system, you can treat even challenging tricuspid anatomies in more patients with TR, and get predictable capture, positioning and release for patients with MR.

PASCAL central spacer
PASCAL elongation
PASCAL independent clasps
PASCAL nitol
PASCAL unique design clasps
PASCAL central spacer
PASCAL elongation
PASCAL independent clasps
PASCAL nitol
PASCAL unique design clasps
pascal implant icon pascal ace implant icon

More Opportunity, Lower MR Grades

A unique central spacer is designed to block more jet and minimize MR

Unique Central Spacer

Bridges coaptation gap and reduces stress on fragile leaflets

Implant Elongation

Facilitates safe repositioning within dense chordal structures

Made for Precision

Designed to navigate complex anatomies so you can fine-tune your repair

Nitinol

Spring based passive-closing system respects native anatomy

Optimised Performance

Leaflet capture with independent clasping and atraumatic clasp design

Independent Leaflet Grasping

Independent actuation and distinct clasp design allow leaflet capture optimization while respecting native anatomy

pascal ace implant icon

Narrower Design

Helps to optimize your treatment of mitral and tricuspid regurgitation

Mitral valve repair

The PASCAL platform is designed for predictable capture, positioning and release in patients with MR. The recently introduced PASCAL Ace implant expands your treatment options, allowing you to tailor the procedure to your needs. PASCAL Ace provides a narrow profile designed to improve ease of subvalvular navigation.

Central Spacer

Effectively reduces mechanical strain on the leaflets, avoiding areas of stress concentration

Nitinol design

Spring based passive-closing system respects native anatomy

Clasp design

Single-row retention element orientation designed to reduce the risk of leaflet damage even with multiple recapturing

Watch how it works

Mitral valve repair with PASCAL and PASCAL Ace

Play video Tricuspid valve repair video thumbnail

Tricuspid valve repair

The PASCAL Ace implant is designed for even challenging tricuspid anatomies, instilling confidence to help more of your patients. PASCAL Ace provides a narrow implant profile designed to improve ease of subvalvular navigation.

Clasp design

Single-row retention element orientation designed to reduce the risk of leaflet damage even with multiple recapturing

Implant Elongation

Minimizes risk of chordal entanglement and promotes safe subvalvular maneuvering even in challenging anatomies

Independent Leaflet Grasping​

Independent actuation and distinct clasp design allow leaflet capture optimization while respecting native anatomy​

See how it works

Tricuspid valve repair with PASCAL Ace

Play video Tricuspid valve repair video thumbnail

Watch leading implanters discuss tricuspid leaflet repair therapy

The PASCAL device has some very specific features which make it very appealing to be applied on the tricuspid side.

Philipp Lurz, MD, PhD
Interventional Cardiologist

A new
PASCAL Stabilizer Rail System

Designed to enhance your experience with the PASCAL platform

Increased stability

A new rail-based system with multiple stabilizers to advance, retract, and torque catheters

Intuitive design

Secure stabilizers to allow for stable and incremental movements and fine adjustments

Simplified process

Ease-of-use enhancements help reduce unintended catheter movements throughout the procedure

Play video Tricuspid valve repair video thumbnail

Resources

Procedural videos

PASCAL repair system
Mitral valve treatment

PASCAL repair system Mitral valve treatment

PASCAL repair system Tricuspid valve treatment

PASCAL repair system Tricuspid valve treatment

PASCAL Ace implant system
Mitral valve procedure

PASCAL Ace implant system Mitral valve procedure

PASCAL Ace implant system Tricuspid valve procedure

Animations

Innovation in TR

Innovation in TR

CLASP 1-Year Multi-center Study Results

CLASP 1-Year Multi-center Study Results

PASCAL Ace implant system key features

PASCAL Ace Implant System | Key features video summary

MR

A Therapy Designed for Effective MR Reduction
Clinically and statistically significant improvements

Study design & baseline parameters1

Study Design: Multicenter, multinational, prospective, single-arm study
Total patients: 109 FMR: 67% | DMR: 33%
NYHA Class III/IV: 57.4% MR severity ≥3+: 100%
Mean age: 75.5 years PISA EROA: 0.38 ± 0.16 cm2
Regurgitant volume: 57.2 ± 20.6 ml Mean vena contracta width, A-P: 6.3 ± 1.4 mm

Significant MR reduction: 82% of patients with MR 0-1+ at 1 year

chart showing signigicant MR reduction


TR

Multicenter studies for tricuspid leaflet repair therapy

First-in-human 12 months outcome

In early compassionate use experience, 30 patients with severe or greater TR underwent tricuspid repair therapy with the PASCAL repair system. At 12 months, it demonstrated durable TR reduction* and low mortality. In addition, favorable right ventricular remodeling was sustained at the 12-month follow-up.

Independent
Grasping Use
90%
Residual TR≤2+
12 months
86%
Survival Rate
12 months
93%
NYHA class I or II
12 months
90%

*Site reported TR severity – no Echo Core Lab analysis

CLASP TR Early Feasibility Study 30-day outcome3

34 patients received PASCAL repair system for the treatment of symptomatic TR.

Method

  • 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%

Result 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.

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.

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References

  1. Feldman T, Wasserman HS, Herrmann HC, et al. Percutaneous mitral valve repair using the edge-to-edge technique: six-month results of the EVEREST Phase I clinical trial. J Am Coll Cardiol. 2005;46(11):2134–2140.
  2. Kitamura M, Fam NP, Braun D, et al. 12-Month outcomes of transcatheter tricuspid valve repair with the PASCAL system for severe tricuspid regurgitation. Catheter Cardiovasc Interv. 2021;1-9. http://doi.org/10.1002/ccd.29583
  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 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 Lifesciences 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, CLASP, PASCAL, and PASCAL Ace are trademarks or service marks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

© 2021 Edwards Lifesciences Corporation. All rights reserved. PP--EU-1853 v2.0

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

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