

Edwards PASCAL transcatheter valve repair system
Mitral valve repair: Residual MR matters
In the early days of transcatheter mitral valve repair, the goal was a successful procedure that reduced mitral regurgitation (MR) to less than 3+; residual MR grade 2+ was considered acceptable.1,2
Compelling new data on more than 5400 patients show that residual MR grades 0–1+ are significantly associated with superior patient outcomes when compared with residual MR 2+, including reduced mortality and rehospitalisation.3–8
Lower MR grades are
within your clasp

More Opportunity, Lower MR Grades
A unique central spacer is designed to block
more jet and minimise MR

Independent Leaflet Grasping
Independent actuation and distinct clasp
design allow leaflet capture precision while
respecting native anatomy

Device Elongation
Device elongation feature optimises subvalvular manoeuvrability when you need it
A new
PASCAL Stabilizer
Rail System
Designed to enhance your experience with the PASCAL platform
A Therapy Designed for Effective MR Reduction
Clinically and statistically significant improvements at 12 months
Study design & baseline parameters1
Study Design: Multicenter, multinational, prospective, single-arm study | |
---|---|
Total patients: 109 | FMR: 67% | DMR: 33% |
NYHA Class III/IV: 57.4% | MR severity ≥3+: 100% |
Mean age: 75.5 years | PISA EROA: 0.38 ± 0.16 cm2 |
Regurgitant volume: 57.2 ± 20.6 ml | Mean vena contracta width, A-P: 6.3 ± 1.4 mm |
Significant MR reduction: 82% of patients with MR 0-1+ at 1 year
High Survival Rate at 12 months
See how it works
Watch the PASCAL repair system procedural animation
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Learn more about Edwards' transcatheter mitral
and tricuspid portfolio
- Feldman T, Wasserman HS, Herrmann HC, et al. Percutaneous mitral valve repair using the edge-to-edge technique: six-month results of the EVEREST Phase I clinical trial. J Am Coll Cardiol. 2005;46(11):2134–2140.
- Feldman T, Foster E, Glower DD, et al. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med. 2011;364(15):1395–1406.
- Patzelt J, Zhang W, Sauter R, et al. Elevated mitral valve pressure gradient is predictive of long-term outcome after percutaneous edge-to-edge mitral valve repair in patients with degenerative mitral regurgitation (MR), but not in functional MR. J Am Heart Assoc. 2019;8(13):e011366.
- Sorajja P, Vemulapalli S, Feldman T, et al. Outcomes with transcatheter mitral valve repair in the United States. An STS/ACC TVT Registry report. J Am Coll Cardiol. 2017;70(19):2315–2327.
- Tabata N, Weber M, Sugiura A, et al. Impact of the leaflet-to-annulus index on residual mitral regurgitation in patients undergoing edge-to-edge mitral repair. JACC Cardiovasc Interv. 2019;12(24):2462–2472.
- Surder D, Pedrazzini G, Gaemperli O et al. Predictors for efficacy of percutaneous mitral valve repair using the MitraClip system: the results of the MitraSwiss registry. Heart. 2013; 99: 1034–40
- Suri RM, Clavel M, Schaff HV et al. Effect of recurrent mitral regurgitation following degenerative mitral valve repair. J Am Coll Cardiol 2016;67:488–98
- Reichart D, Kalbacher D, Rubsamen N et al. The impact of residual mitral regurgitation after mitraclip therapy in functional mitral regurgitation. Eur J Heart Fail. 2020. doi: 10.1002/ejhf.1774
- Lim DS, Kar S, Spargias K, et al. Transcatheter valve repair for patients with mitral regurgitation: 30-day results of the CLASP study. JACC Cardiovasc Interv. 2019;12(14):1369-1378.
For professional use
Edwards 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.
Caution- Investigational device in the United States. Limited by federal (or United States) law to investigational use.
Edwards, Edwards Lifesciences, the stylized E logo, Cardioband, CLASP, PASCAL, Valtech, and Valtech Cardio are trademarks or service marks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.
© 2020 Edwards Lifesciences Corporation. All rights reserved. PP--EU--0504 v1.0
Edwards Lifesciences • Route de l’Etraz 70, 1260 Nyon, Switzerland • edwards.com
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