CI read Most device pivotal trials are run against medical therapy, because the comparison is easier to win and approval is the objective. VDyne has done something else. A privately held company with no approved product has chosen to randomise its pivotal study one to one against the commercially available market leader, which raises the bar it must clear and changes what a win is worth. Approval against medical therapy gets a device onto the market; a randomised result against EVOQUE would give TriNova a comparative claim from day one, in a field where the incumbent already holds the accounts, the proctoring relationships and the operator familiarity. It also raises the cost of losing, because a tie against an approved competitor is a much harder commercial position than a win against placebo. Set it beside Abbott this week, which began a single-arm post-market study of its TriClip repair system to build the durability file payers want. Within 48 hours the tricuspid field produced two opposite evidence strategies: an approved device generating data for coverage, and an unapproved one going straight at the leader for superiority. Behind both sits the unresolved question of whether the tricuspid valve should be repaired or replaced, and these two trials are the first serious attempt to answer it with comparative evidence rather than assertion.