Tricuspid Regurgitation (TR) is Largely
Untreated Despite High Mortality Rates
Patients with tricuspid regurgitation (TR) are rarely surgically treated1, are medically managed, and often experience debilitating symptoms. While the prevalence of TR and the associated mortality rates for severe TR are high2,3, limited treatment options exist.
The Edwards PASCAL transcatheter valve repair system adds to TMTT’s portfolio of TR treatment options and is designed to treat both mitral and tricuspid regurgitation, improving patient symptoms and quality of life using the same device.
An innovative system designed to address the complexity of tricuspid repair
Independent grasping for optimal placement while
respecting native anatomy
- Atraumatic clasps with a single row of retention elements designed for fragile leaflets
- Staged capture and capture optimization facilitate maximum leaflet insertion
Central spacer effectively bridges the coaptation gap
- Broad, contoured paddles increase coaptation area
- Spacer reduces leaflet stress and increases open orifice area
Safely navigate your procedure within the
- Implant elongation facilitates safe repositioning in dense tricuspid chordae
- Independent catheters allow for predictable implant positioning
The PASCAL repair system shown promising in First-in-Human experience4,5,*
In early compassionate use experience, the PASCAL repair system demonstrated high procedural success, significant clinical improvements, and sustainable TR reduction in patients with challenging tricuspid anatomy and severe TR. In addition, favorable right ventricular remolding was observed at the 30-days follow-up.
Acute (TR ≤2+)
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Learn more about Edwards' transcatheter mitral
and tricuspid portfolio
- Fender EA, Zack CJ, Nishimura RA. Isolated Tricuspid Regurgitation: Outcomes and Therapeutic Interventions. Heart 2018;104:798–806.
- Topilsky Y et al. Burden of Tricuspid Regurgitation in Patients Diagnosed in the Community Setting. JACC Cardiovasc Imaging 2018 Aug 6. Epub 2018 Aug 6
- Nath J, Foster E, Heidenreich PA. Impact of tricuspid regurgitation on long-term survival. J Am Coll Cardiol. 2004;43:405-409.
- Fam NP et al. Compassionate Use of the PASCAL Transcatheter Valve Repair System for Severe Tricuspid Regurgitation: A Multicenter, Observational, First-in-Human Experience. J Am Coll Cardiol. 2019;12(24).
- Lurz P et al. Six-month results of the PASCAL transcatheter valve repair system for severe tricuspid regurgitation: a multicentre, observational, first-in-human experience. PCR e-course 2020. 2020 June. Euro20A-POS487.
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.
Edwards, Edwards Lifesciences, the stylized E logo, Cardioband, PASCAL, Valtech, and Valtech Cardio are trademarks or service marks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.
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