Mitralign — From EU Delays to a Faster FIH Path via Colombia

Mitralign was developing a percutaneous annuloplasty system for mitral valve repair but faced delays at EU sites in Poland and Germany. By shifting FIH work to Colombia with bioaccess® support, Mitralign obtained ethics approval, enrolled 11 patients, and moved its EU submission ahead of the original schedule.

Study facts

Key metrics

The challenge

Mitralign's percutaneous annuloplasty system for mitral valve repair was stalled by regulatory and site-readiness delays at EU clinical sites in Poland and Germany, jeopardizing their development timeline and investor commitments.

bioaccess® solution

bioaccess® redirected the FIH program to Colombia, securing ethics approval. The clinical team enrolled 11 patients and generated the safety and feasibility data needed for EU submission ahead of the original schedule.

Results

Frequently asked

What did bioaccess® do for Mitralign?
bioaccess® redirected the FIH program to Colombia, securing ethics approval. The clinical team enrolled 11 patients and generated the safety and feasibility data needed for EU submission ahead of the original schedule.
Where was the Mitralign First-in-Human (FIH) study run?
The Mitralign First-in-Human (FIH) study was executed in Colombia by bioaccess® in the structural heart area.
What was the outcome of the Mitralign study?
Reported outcomes for Mitralign's device: Ethics approval in 18 days (Clinical Research News, 14 Aug 2025); 11 patients enrolled in 8 weeks (Clinical Research News, 14 Aug 2025); FIH data package accepted for EU regulatory review.

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