PASCAL Implant
Designed to minimize stress on leaflets and
reduce risk of leaflet tears
PASCAL Precision System
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 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¶
*Performance data on file and marketing evaluation.
§Design and performance data on file and marketing evaluation.
¶Design data on file and marketing evaluation.
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 retract the implant as needed
A wide range of paddle mobility and full elongation capabilities
Closed
Leaflet Capture
Elongated
†Performance data on file.
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
‡Performance and simulation data on file.
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†
†Performance data on file.
Clinical evidence
Learn about outcomes from a large randomized trial, early feasibility studies (EFS) and real-world studies
Currently published data from some studies 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 transcatheter edge-to-edge repair (TEER) therapies
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aTEE was used for baseline qualification of 5 patients.
Currently published data from some studies were collected before the availability of the PASCAL Precision delivery system
Valve Repair with the PASCAL repair system
Tricuspid Regurgitation
PASTE: PASCAL for Tricuspid Regurgitation - a European registry*
Retrospective, observational, multicenter study including 524 patients
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TR = Tricuspid Regurgitation
*Expert opinions, advice and all other information expressed represent contributors' views and not necessarily those of Edwards Lifesciences
Currently published data from some studies were collected before the availability of the PASCAL Precision delivery system
Video testimonials
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References
- Zahr F, Smith RL, Gillam LD, et.al. One-year Outcomes from the CLASP IID Randomized Trial for Degenerative Mitral Regurgitation. J Am Coll Cardiol Intv 2023; Oct 26; [Epub Ahead of Print]; DOI: https://doi.org/10.1016/j.jcin.2023.10.002
- Spargias K, et al. Three-year outcomes for transcatheter repair in patients with mitral regurgitation from the CLASP study. Catheter Cardiovasc Interv. 2023; 102(1):145-154.
- 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.
- Kodali S, et al. 1-Year outcomes of transcatheter tricuspid valve repair. J Am Coll Cardiol. 2023 May 9; 81(18): 1766-1776.
- Wild M., Transcatheter leaflet repair for tricuspid regurgitation: one-year results from the PASTE registry. Transcatheter tricuspid interventions: emerging evidence, PCR London Valves, 29 Nov. 2022.
- 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 unpaired 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).