Mitralign — Advancing Percutaneous Mitral Annuloplasty in LATAM
Mitralign developed a transcatheter mitral valve repair system for functional mitral regurgitation. bioaccess® managed clinical studies in Latin America to expand the evidence base for this novel structural heart therapy.
Study facts
- Sponsor / company: Mitralign
- Indication / area: Structural Heart
- Country: Colombia, Brazil
- Study type: Clinical Study
Key metrics
- Therapy: Mitral repair
- Countries: 2
- Approach: Transcatheter
- Sites: Multi-center
The challenge
Mitral regurgitation affects millions of patients who are often too high-risk for open-heart surgery. Mitralign needed clinical data from diverse populations to support their percutaneous annuloplasty approach and strengthen their competitive position in the emerging transcatheter mitral repair market.
bioaccess® solution
bioaccess® coordinated clinical studies across structural heart programs in Colombia and Brazil, managing patient selection with echocardiographic screening, catheterization lab logistics, procedural data capture, and long-term echocardiographic follow-up.
Results
- Clinical studies completed across multiple LATAM structural heart centers
- Echocardiographic data demonstrated reduction in mitral regurgitation
- Safety profile consistent with global clinical experience
- Data expanded the global evidence base for transcatheter mitral repair
- Supported Mitralign's strategic positioning in the structural heart space
Frequently asked
- What did bioaccess® do for Mitralign?
- bioaccess® coordinated clinical studies across structural heart programs in Colombia and Brazil, managing patient selection with echocardiographic screening, catheterization lab logistics, procedural data capture, and long-term echocardiographic follow-up.
- Where was the Mitralign Clinical Study study run?
- The Mitralign Clinical Study study was executed in Colombia, Brazil by bioaccess® in the structural heart area.
- What was the outcome of the Mitralign study?
- Reported outcomes for Mitralign's device: Clinical studies completed across multiple LATAM structural heart centers; Echocardiographic data demonstrated reduction in mitral regurgitation; Safety profile consistent with global clinical experience.
Run a similar trial: Clinical trials in Colombia · Clinical trials in Brazil
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