Clear Path currently uses Elixir's clinical page as its evidence layer. It should be using it as the claim layer, because that's what it is. Elixir's BIOADAPTOR RCT page reports favorable TLF (target lesion failure: the composite of cardiac death, heart attack in the treated vessel, and repeat intervention at the stent site), CE Mark status (European device clearance), and a U.S. investigational disclaimer. The numbers are real. They appear in peer-reviewed journals and conference coverage. But Elixir selects which endpoints to emphasize. When TCTMD covered the same four-year data in May 2026, outside cardiologists noted that the components driving the TLF gap were only numerically lower, not statistically significant. Elixir's page omits this. Three sources close the gap: ClinicalTrials.gov for trial state, the FDA PMA database (the FDA's most stringent pathway for high-risk devices) for U.S. authorization, and TCTMD for clinical interpretation. Without them, Clear Path is Elixir's narrative with better prose, and a customer can get that from any competent medical writer.
ClinicalTrials.gov — answers trial status and endpoint structure. INFINITY-SWEDEHEART (2,400 patients) hit primary completion September 2024; results not yet posted as of June 2026. Elixir's page doesn't surface this.
FDA PMA database — tracks whether DynamX has U.S. marketing authorization. It does not. CE Mark does not predict FDA timing. Elixir received Breakthrough Device Designation in June 2024, but designation is not approval. FDA's authorized breakthrough device list does not include Elixir as of March 2026.
TCTMD — surfaces whether cardiologists found results practice-changing. At EuroPCR 2024, Robert Byrne urged caution about secondary analyses in later follow-up. At EuroPCR 2023, Ron Waksman questioned whether hospitals would pay more without hard outcome reductions. Elixir's page reports none of this.