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.
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
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
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
Watch leading implanters discuss the PASCAL repair system
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
![Youtube thumbnail Doctor Phillip Lurz](http://edwardsprod.blob.core.windows.net/media/Gb/devices/heart%20valves/pascal-confidence/video-thumb-philipp-lurz1.jpg")
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
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
Resources
Procedural videos
Animations
MR
CLASP study shows sustained MR reduction and positive left ventricular remodeling accompanied by high survival and low HF Hospitalization rate
Study design & baseline parameters1
| Study Design: Multicenter, multinational, prospective, single-arm study | |
|---|---|
| Total patients: 124 | FMR: 69% | DMR: 31% |
| Baseline NYHA Class III/IV: 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: 6.3 ± 1.4 mm |
Robust and significant MR Reduction at 2 years
TR
Multicenter studies for tricuspid leaflet repair therapy
First-in-human 12 month outcome2
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.
Grasping Use 90%
12 months 86%
12 months 93%
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%
- Mean age 76 years
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.
References
- Lim S, et al.2-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study. J Am Coll Cardiol. 2021;14(14):1538-1548.
- 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.
- Kodali S, Hahn RT, Eleid MF, et al. Feasibility study of the transcatheter valve repair system for severe tricuspid regurgitation. J Am Coll Cardiol. 2021;77(4):345-356.
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 v3.0
Edwards Lifesciences • Route de l’Etraz 70, 1260 Nyon, Switzerland • edwards.com
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