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PASCAL Precision System

For treating mitral and tricuspid regurgitation

PASCAL Precision System background image
PASCAL Precision System background image
PASCAL Precision System background image

Meet the PASCAL
Precision System

Introducing the latest advancement from Edwards Lifesciences in transcatheter mitral and tricuspid therapies

Meet the PASCAL Precision System Image
Meet the PASCAL Precision System Image
Meet the PASCAL Precision System Image

Two distinct designs and same functionality

PASCAL Implant

Designed to minimize stress on leaflets and
reduce risk of leaflet tears

PASCAL Ace Implant

Features a narrower design profile to help you optimize your
treatment of mitral and tricuspid regurgitation

Features

Treat your patients with mitral and
tricuspid regurgitation with the latest
transcatheter innovation from Edwards
Lifesciences

Features Image
Features Image
Features Image

Designed for precise placement with accurate, intuitive control*

Advanced catheter and handle design facilitates smooth navigation and implant deployment

Catheter design
Catheter design
Catheter design

Catheter design

Responsive catheter design with optimized torque transfer to facilitate implant placement§

Ergonomic handle design
Ergonomic handle design
Ergonomic handle design

Ergonomic handle design

Handle controls engineered for intuitive manipulation, allowing the user to focus on treating the patient

*Performance data on file and marketing evaluation.
§Design and performance data on file and marketing evaluation.
¶Design data on file and marketing evaluation.

Starting the procedure with the PASCAL Precision system


Navigate a range of challenging anatomies with versatile implant configuration3,†

Adapt to specific procedural and anatomical needs

Maneuver, reconfigure and retract the implant as needed

A wide range of paddle mobility and full elongation capabilities

Closed Pascal Image
Closed Pascal Image
Closed Pascal Image

Closed

Leaflet Capture
Leaflet Capture
Leaflet Capture

Leaflet Capture

Elongated
Elongated
Elongated

Elongated

†Performance data on file.

Watch how the PASCAL Precision system can adapt to specific procedural and anatomical needs


Atraumatic clasp and closure help you preserve leaflet integrity

Enhance leaflet capture with atraumatic reclasp capabilities

Independent and simultaneous clasping
Independent and simultaneous clasping
Independent and simultaneous clasping

Independent and simultaneous clasping

Each paddle features a single row of retention elements to clasp, reclasp, and preserve leaflets

Nitinol Construction
Nitinol Construction
Nitinol Construction

Nitinol Construction

Close the implant to conform to native anatomy and flex during the cardiac cycle

‡Performance and simulation data on file.

Clasp and closure with the PASCAL Precision system


Post-implant release predictability you expect2,†

Deploy the implant with procedural confidence

Predictable release

With an implant designed to adapt to native anatomies and a catheter with balanced flexibility, what you see before release is what you can achieve

Predictable release
Predictable release
Predictable release
Predictable release
Predictable release
Predictable release

Predictable release with the PASCAL Precision system


†Performance data on file.

Clinical evidence

Learn about outcomes from a large randomized trial, early feasibility studies (EFS) and real-world studies

Currently published data from some studies were collected before the availability of the PASCAL Precision delivery system

Trial Logos
Trial Logos
Trial Logos
Valve Repair With PASCAL Platform

Mitral Regurgitation

CLASP IID trial

Prospective, multicenter, randomized controlled trial to directly compare the safety and effectiveness of two contemporary transcatheter edge-to-edge repair (TEER) therapies

aTEE was used for baseline qualification of 5 patients.

CLASP Clinical Study

Multicenter, prospective, single-arm study (n=124)

CLASP Clinical Study
CLASP Clinical Study
CLASP Clinical Study

Post-Release Predictability Evaluation

Single-center, retrospective analysis from 2017-2020
(PASCAL n=100, MitraClip n=100)

Post-Release Predictability Evaluation
Post-Release Predictability Evaluation
Post-Release Predictability Evaluation

MR = mitral regurgitation.
Deteriorated: reoccurrence of MR due to new jet, increase of residual MR, and/or return of MR

Currently published data were collected before the availability of the PASCAL Precision delivery system
Currently published data were collected before the availability of the PASCAL Precision delivery system
Currently published data were collected before the availability of the PASCAL Precision delivery system

Currently published data from some studies were collected before the availability of the PASCAL Precision delivery system

Valve Repair with the PASCAL repair system

Tricuspid Regurgitation

CLASP TR Clinical Study

Multicenter, prospective, single-arm study (n=65)

CLASP TR Clinical Study
CLASP TR Clinical Study
CLASP TR Clinical Study

aWilcoxon signed rank test

PASTE: PASCAL for Tricuspid Regurgitation - a European registry*

Retrospective, observational, multicenter study including 524 patients

TR = Tricuspid Regurgitation
*Expert opinions, advice and all other information expressed represent contributors' views and not necessarily those of Edwards Lifesciences

Currently published data were collected before the availability of the PASCAL Precision delivery system
Currently published data were collected before the availability of the PASCAL Precision delivery system
Currently published data were collected before the availability of the PASCAL Precision delivery system

Currently published data from some studies were collected before the availability of the PASCAL Precision delivery system

Video testimonials

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References

  1. Zahr F, Smith RL, Gillam LD, et.al. One-year Outcomes from the CLASP IID Randomized Trial for Degenerative Mitral Regurgitation. J Am Coll Cardiol Intv 2023; Oct 26; [Epub Ahead of Print]; DOI: https://doi.org/10.1016/j.jcin.2023.10.002
  2. Spargias K, et al. Three-year outcomes for transcatheter repair in patients with mitral regurgitation from the CLASP study. Catheter Cardiovasc Interv. 2023; 102(1):145-154.
  3. Fam N, et al. Compassionate Use of the PASCAL Transcatheter Valve Repair System for Severe Tricuspid Regurgitation. JACC Cardiovasc Interv. 2019; 12(24):2488-2495.
  4. Kodali S, et al. 1-Year outcomes of transcatheter tricuspid valve repair. J Am Coll Cardiol. 2023 May 9; 81(18): 1766-1776.
  5. Wild M., Transcatheter leaflet repair for tricuspid regurgitation: one-year results from the PASTE registry. Transcatheter tricuspid interventions: emerging evidence, PCR London Valves, 29 Nov. 2022.
  6. Lüdike P, Riebisch M, Schindhelm F et al. Impact of mitral valve repair technologies on predictability of post-delivery residual mitral regurgitation. JACC Cardiovasc Interv. 2021; 14: 2638-40.
  7. Cardiovascular Research Foundation, Graph shows unpaired data. Two patients initially considered to have severe TR at baseline by transoesophageal echocardiography were reclassified as moderate TR by transthoracic echocardiography.

Medical device 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).