Meet the PASCAL Precision System

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

PASCAL devices

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

image of features

Designed for precise placement with accurate, intuitive control*

Advanced catheter and handle design facilitates smooth navigation and implant deployment

Catheter design

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

image of catheter design

Ergonomic handle design

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

image of handle and actuation

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 retrieve the implant as needed

A wide range of paddle mobility and full elongation capabilities

device closed

Closed

device leaflet capture

Leaflet Capture

device elongated

Elongated

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

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

image of independent, simultaneous

Nitinol Construction

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

image of Nitinol

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

device released
device deployed

Predictable release with the PASCAL Precision system

Clinical evidence

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

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

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 TEER therapies

MR Reduction

clasp-IID-slide-1

CEC-adjudicated Major Adverse Events at 30 Days

clasp-IID-slide-2

New York Heart Association Functional Class at 6 Months

clasp-IID-slide-3

CLASP Clinical Study

CLASP TR Clinical graph

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

See the full CLASP study summary

Post-Release Predictability Evaluation

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

Post-Release Predictability Evaluation graph

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

MR = mitral regurgitation.

Valve Repair with the PASCAL repair system

Tricuspid Regurgitation

CLASP TR Clinical Study

Clasp TR graph

b Wilcoxon signed-rank test

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

See more

PASTE: PASCAL implant for TR - a European registry

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

TR Severity Grade at Discharge and 6 months

PASCAL-ACE-slide-1

NYHA class

PASCAL-ACE-slide-2

Multicenter, retrospective study (n=86)

TR = Tricuspid Regurgitation

Video testimonials

One of the features of the PASCAL device that makes me feel much more comfortable treating complex anatomy, is that you can elongate it, so you’re very very unlikely to get stuck.

Dr. Sam Dawkins

I think it’s a good device, it’s safe, predictable, and easy to use. If a hospital has a department for the treatment of MR and TR, I think this is a device that must be in there.

Dr. Jose Antonio Baz Alonso

We appreciate the PASCAL valve repair system as being one very important device in the toolbox of valve repair devices. And this is, I think, important for the future.

Dr. Ralph Stephan von Bardeleben
Interventional Cardiologist

You cannot compare this system; it’s totally different to other available systems we used in the past. In my opinion, it improves our treatment option for the patients.

Dr. Christian Frerker
Interventional Cardiologist

The introduction of both PASCAL systems substantially extended our toolbox for treating patients with mitral regurgitation.

Dr. Roman Pfister
Interventional Cardiologist

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

Dr. Phillip Lurz, MD, PhD
Interventional Cardiologist

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

References

  1. Lim S, et al. Randomized Comparison of Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients. JACC Cardiovasc Interv. 2022 Sep 8;S1936- 8798(22)01704-6. doi: 10.1016/j.jcin.2022.09.005. Online ahead of print.
  2. Szerlip M, et al. 2-Year outcomes for transcatheter repair in patients with mitral regurgitation from the CLASP study. JACC Cardiovasc Interv. 2021; 14(14):1538-1548
  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.M
  4. Hahn R. Transcatheter tricuspid valve repair: CLASP TR study one-year results. EuroPCR LTB 2022
  5. Hausleiter J. A patient focused transcatheter portfolio of options to treat TR. Edwards TNT, EuroPCR, 17–20 May 2022, Paris, France.
  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 paired 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

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).

© 2022 Edwards Lifesciences Corporation. All rights reserved. PP--EU-3483 v1.0

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

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