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

Click to view MR 0-1+ evidence

Lower MR grades are
within your clasp

PASCAL spacer

More Opportunity, Lower MR Grades

A unique central spacer is designed to block more jet and minimise MR

PASCAL Independent Leaflet Grasping

Independent Leaflet Grasping

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

PASCAL elongation feature

Device Elongation

Device elongation feature optimises subvalvular manoeuvrability when you need it

Get the full story on lower MR grades

A Therapy Designed for Effective MR Reduction

Clinically and statistically significant improvements at 12 months

The CLASP STUDY

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

Significant MR reduction: 82% of patients with MR 0-1+ at 1 year


High Survival Rate at 12 months

High Survival Rate at 12 months

See the Full Study Results

See how it works

Watch the PASCAL repair system procedural animation

Register for PASCAL repair system updates

Sign up now to receive event and news information from Edwards Lifesciences including:

  • Publications
  • Congress highlights
  • Webinar invites
  • Product announcements and updates

Learn more about Edwards' transcatheter mitral and tricuspid portfolio

Makeamark icon

MakeAMark.com

Get to know all of our transformational mitral and tricuspid therapies

Learn more
References
  1. 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.
  2. Feldman T, Foster E, Glower DD, et al. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med. 2011;364(15):1395–1406.
  3. 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.
  4. 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.
  5. 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.
  6. 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
  7. 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
  8. 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
  9. 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

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).

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).

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

Please update your browserClose this window

Please update to a current version of your preferred browser, this site will perform effectively on the following:

Unable to update your browser?

If you are on a computer, that is maintained by an admin and you cannot install a new browser, ask your admin about it. If you can't change your browser because of compatibility issues, think about installing a second browser for browsing and keep this old one for compatibility