Accurate, Intuitive Control
Versatile Implant Configuration
Atraumatic Clasp and Closure
Predictable Release
Meet the PASCAL Precision System
Introducing the latest advancement from Edwards Lifesciences in transcatheter mitral and tricuspid therapies
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
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§
Ergonomic handle design
Handle controls engineered for intuitive manipulation, allowing the user to focus on treating the patient¶
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
Closed
Leaflet Capture
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
Nitinol Construction
Close the implant to conform to native anatomy and flex during the cardiac cycle
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 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
CLASP Clinical Study
Post-Release Predictability Evaluation
Currently published data were collected before the availability of the PASCAL Precision delivery system
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
b Wilcoxon signed-rank test
Study Design: Multicenter, prospective, single-arm study (n=65)
See morePASTE: PASCAL implant for TR - a European registry
Currently published data were collected before the availability of the PASCAL Precision delivery system
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
- 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.
- 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
- 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
- Hahn R. Transcatheter tricuspid valve repair: CLASP TR study one-year results. EuroPCR LTB 2022
- Hausleiter J. A patient focused transcatheter portfolio of options to treat TR. Edwards TNT, EuroPCR, 17–20 May 2022, Paris, France.
- 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.
- 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.
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).
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