Laplace Interventional is taking on an approved tricuspid valve with TRIUMPH, but can its new implant deliver better outcomes?
Laplace Interventional has treated the first three patients in its FDA-authorised TRIUMPH pivotal trial, moving its investigational tricuspid valve into a randomised comparison with commercial replacement technology. With approximately 400 patients planned for the main study, the company must demonstrate meaningful safety and effectiveness in an increasingly competitive structural heart market.