*Performance data on file and marketing evaluation
One system, two clasps in your hands
Now with the PASCAL repair system, you can treat even challenging tricuspid anatomies in patients with TR,1* and get predictable capture, positioning and release for patients with MR.
Effective MR Reduction
Designed to close the regurgitant orifice 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
Nitinol
Spring based passive-closing system respects native anatomy
Optimised Performance
Leaflet capture with independent clasping and atraumatic clasp design
Narrower Design
Helps to enhance your treatment of mitral and tricuspid regurgitation
*Instructions for use
Mitral valve repair
The PASCAL platform is designed for predictable capture, positioning and release in patients with MR. The 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
*Data on file
Watch how it works
Mitral valve repair with PASCAL and PASCAL Ace
Tricuspid valve repair
The PASCAL Ace implant is designed for even challenging tricuspid anatomies,1* 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 enhance leaflet capture while respecting native anatomy
*Instructions for use
See how it works
Tricuspid valve repair with PASCAL Ace
Watch leading implanters discuss the PASCAL repair system
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
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
PASCAL Stabilizer Rail System
Designed to enhance your experience with the PASCAL platform
Increased stability
A 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
Resources
Procedural videos
MR
CLASP study shows sustained MR reduction and positive left ventricular remodeling accompanied by high survival and low HF Hospitalization rate
Study design & baseline parameters2
| Study Design: Multicenter, prospective, single-arm study | |
|---|---|
| Total patients: 124 | FMR: 69% | DMR: 31% |
| Baseline NYHA Class III/IVa: 60.2% | MR severity ≥3+: 100% |
| Mean age: 74.9 years | PISA* EROA: 0.38 ± 0.15 cm2 |
| Regurgitant volume*: 57.3 ± 19.7 ml | Mean vena contracta width, A-P (TTE): 6.3 ± 1.4 mm |
*Limited sample size due to difficulty in measuring small regurgitant volumes
Robust and significant MR Reduction at 2 years
TR
Multicenter studies for tricuspid leaflet repair therapy
CLASP TR Study: One-year outcomes3
During the late-breaking trial session presented at EuroPCR2022, Prof Rebecca Hahn reported the one-year outcomes from the prospective, single-arm, multicentre CLASP TR study. A total of 65 patients with symptomatic severe tricuspid regurgitation who were deemed appropriate for transcatheter tricuspid valve repair across 14 sites were enrolled out of which 46 had reached one-year follow-up at the time of the analysis.
Study design & baseline parameters
| Study Design: Prospective, single-arm, multicentre study | |
|---|---|
| Enrolled patients: 65 | Female: 55% |
| NYHA functional class III or IV: 71% | Tricuspid regurgitation (≥ severe)†: 97%*a |
| Age, years: 77 ± 9 | EuroSCORE II: 5.0 ± 4.7¶ |
Key results
1Cardiovascular 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.
†Cardiovascular Research Foundation.
*N=64.
¶ N=62.
aTR severity for one patient was deemed inconclusive after core laboratory adjudication.
bWilcoxon signed-rank test.
TR: tricuspid regurgitation
- Sustained TR reduction at one year:
- 86% achieving moderate or less TR
- 100% had ≥ 1 grade reduction and 75% had ≥ 2 grade reduction
- A 56% reduction in the rate of annualised heart failure hospitalisation
- Significant improvements in NYHA class, KCCQ and 6MWD score were sustained at one year
- Overall mortality was 10.8% (cardiovascular mortality was 7.7%) at one year
*Pre-enrollment HFH data collected via site-reported medical history. Post-procedure HFH data was CEC adjudicated. Error bars represent 95% confidence interval. P value derived from two sample z test for incidence rate ratio on natural log scale. aWilcoxon signed-rank test. bPaired t-test. HFH, heart failure hospitalisation; NYHA, New York Heart Association; KCCQ, Kansas City Cardiomyopathy Questionnaire; 6MWD, 6-minute walk distance.
Conclusion
- At one year, transcatheter tricuspid valve repair with the PASCAL system demonstrated favourable safety and performance.
- Significant reduction in TR severity and improvements in clinical, functional, and quality of life outcomes were sustained at one year.
References
- Fam NP, Braun D, von Bardeleben RS, et al. Compassionate use of the PASCAL transcatheter valve repair system for severe tricuspid regurgitation: a multicenter, observational, first-in-human experience. JACC Cardiovasc Interv. 2019;12(24): 2488-2495.
- Szerlip M, et al. 2-Year outcomes for transcatheter repair in patients with mitral regurgitation from the CLASP study. JACC Cardiovasc Interv. 2021 Jul 26;14(14):1538-1548.
- Hahn R. Transcatheter tricuspid valve repair:CLASP TR study one-year results. EuroPCR LTB 2022.
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, Edwards Lifesciences, the stylized E logo, CLASP, PASCAL, PASCAL Ace and PASCAL Precision are trademarks or service marks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.
© 2022 Edwards Lifesciences Corporation. All rights reserved. PP--EU-1853 v4.0
Edwards Lifesciences • Route de l’Etraz 70, 1260 Nyon, Switzerland • edwards.com
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