Direct Flow Medical developed a percutaneous aortic valve replacement system with a unique non-metallic, retrievable, and repositionable design. bioaccess® supported clinical studies in Latin America to expand the global evidence base.
The TAVR market was dominated by established players. Direct Flow Medical needed differentiated clinical data from diverse patient populations to support their unique valve design's competitive positioning and expand into new markets.
bioaccess® managed clinical study sites across Colombia and Brazil, coordinating with structural heart teams experienced in TAVR procedures. Our team oversaw patient selection, procedural data capture, echocardiographic follow-up, and adverse event reporting aligned with global standards.