Pour le canadien français, veuillez suivre ce lien.

Skip to main content
Edwards Lifesciences Logo

The PASCAL Precision System

PASCAL Precision System background image

Meet the PASCAL
Precision System

The latest advancement from Edwards Lifesciences in transcatheter mitral therapies: The PASCAL Precision system

Meet the PASCAL Precision System Image

Discover the difference with the PASCAL implants

Designed for patient-focused care

PASCAL implant

Designed to reduce leaflet stress and increase open orifice area enabling low gradients

PASCAL Ace implant

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

The PASCAL Ace image

The PASCAL Ace and PASCAL implants offer different designs with the same functionality.

Features

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

Features Image

Versatile implant configuration to navigate even challenging anatomies

Adapt to specific procedural and anatomical needs

Versatile implant configuration image

A wide range of paddle mobility and full elongation capabilities helps you maneuver, reconfigure, and retrieve the implant prior to release

Overview of the PASCAL Precision system

Advanced catheter technologies facilitate smooth navigation and implant deployment

Overview of the PASCAL Precision system image

Watch the PASCAL Precision system in action

Clinical evidence

CLASP IID Randomized Control Trial (RCT): The first and only RCT to directly compare two contemporary TEER therapy in patients with DMR.

CLASP IID Registry: A first-of-its-kind registry to evaluate the PASCAL system in DMR patients with complex anatomy.

CLASP: The first international, multicenter study to evaluate the safety and clinical outcomes of the PASCAL system.

Features Image

CLASP IID trial

The objective of this prospective, multicenter, randomized, controlled pivotal trial is to evaluate safety and effectiveness in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team.

1 / 5
mr severity
Freedom all-cause mortality
freedom from hfh
New York Heart Association Functional Class at 6 Months
kccq score
mr severity

MR Reduction

Freedom all-cause mortality

Freedom from cardiovascular mortality

freedom from hfh

Freedom from heart failure hospitalization

New York Heart Association Functional Class at 6 Months

New York Heart Association Functional Class

kccq score

KCCQ Score

Mitral regurgitation (MR) severity reduction

79%

of patients sustained MR ≤ 1+ at 2 years with the PASCAL system1

Freedom from cardiovascular mortality

89%

freedom from cardiovascular mortality at 2 years with the PASCAL system

Freedom from heart failure hospitalization (HFH)

86%

freedom from HFH at 2 years with the PASCAL system

New York Heart Association (NYHA) functional class

88%

of patients achieved NYHA Class I/II at 2 years with the PASCAL system

Graph shows unpaired analysis for NYHA functional class (mean ±SD). P values for intragroup comparison for NYHA were calculated from paired analysis using the Wilcoxon signed rank test. P values for intergroup comparison of NYHA functional class I/II were calculated using Fisher exact test. 

Kansas City Cardiomyopathy Questionnaire (KCCQ)

17

point improvement from baseline to 2 years with the PASCAL system

Graph shows unpaired analysis for KCCQ (mean ±SD). P value for intergroup comparison of KCCQ score was calculated using the analysis of covariance (ANCOVA) model adjusted for baseline values and planned treatment as covariates.

1. Zahr F, et al. CLASP IID Randomized Trial and Registry: Two-Year Outcomes of Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation.  Presented at: TCT Annual Congress; 2024 Oct 30; Washington, DC.

The PASCAL Ace image

CLASP IID is a clinical trial from Edwards Lifesciences, reinforcing TEER as safe and effective for the treatment of patients with degenerative mitral regurgitation.

CLASP IID Registry

The objective of this prospective, multinational registry within the construct of the CLASP IID trial is to study significant symptomatic DMR patients with complex mitral valve anatomy deemed suitable for treatment with the PASCAL system.

1 / 4
dmr
Survival
Freedom from HF Rehospitalization
New York Heart Association Functional Class
dmr

MR Reduction

Survival

Freedom from cardiovascular mortality

Freedom from HF Rehospitalization

KCCQ Score

New York Heart Association Functional Class
New York Heart Association Functional Class

Mitral regurgitation (MR) severity reduction

92%

of patients sustained MR ≤2 + at 2 years with the PASCAL system

Freedom from cardiovascular mortality

84%

freedom from cardiovascular mortality at 2 years with the PASCAL system

Kansas City Cardiomyopathy Questionnaire (KCCQ)

12 point

KCCQ improvement from baseline to 2 years with the PASCAL system

New York Heart Association (NYHA) functional class

84%

of patients achieved NYHA Class I/II at 2 years with the PASCAL system

1. Zahr F, et al. CLASP IID Randomized Trial and Registry: Two-Year Outcomes of Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation.  Presented at: TCT Annual Congress; 2024 Oct 30; Washington, DC.

CLASP study

The first, international multicenter study to evaluate the PASCAL system provides 3-year outcomes in patients with clinically significant MR. The results in this section are for the patients in this study with degenerative mitral regurgitation.

1 / 4
Mitral regurgitation (MR) severity reduction image
Freedom from all-cause mortality image
freedom from HFH at 3 years with the PASCAL system image
New York Heart Association (NYHA) functional class image
Mitral regurgitation (MR) severity reduction image

DMR

Freedom from all-cause mortality image

Survival

freedom from HFH at 3 years with the PASCAL system image

Freedom from HF rehospitalization

New York Heart Association (NYHA) functional class image

New York Heart Association Functional Class

Mitral regurgitation (MR) severity reduction

94%

of DMR patients sustained MR ≤ 2+ at 3 years with the PASCAL system2

Freedom from all-cause mortality

92%

freedom from all-cause mortality at 3 years with the PASCAL system

Freedom from heart failure hospitalization (HFH)

91%

freedom from HFH at 3 years with the PASCAL system

New York Heart Association (NYHA) functional class

100%

of DMR patients achieved NYHA Class I/II at 3 years with the PASCAL system

2. Spargias K et al.  Three-year outcomes for the transcatheter repair in patients with mitral regurgitation from the CLASP study.  CCI. 2023.

The PASCAL Ace image

Edwards Lifesciences is invested in building a robust body of clinical evidence, including 5 transcatheter mitral and tricuspid pivotal studies.