BSX · Earnings call · 2026Q3T · Full report

FARAFLEX Trial Readiness and Supply

BOSTON SCIENTIFIC CORP · 2026-10-28 · Importance 9 · Surprise 24

Management cited FDA IDE negotiations, delays in CMS full approval, and operational challenges completing FARAFLEX cases and expanding study sites as factors affecting the program. It said it had just received CMS approval and believed the operational challenges were largely resolved. Management expects the study-supporting supply chain to be robust by year-end and enrollment to ramp in successive weeks and months.

Key facts

• Boston Scientific said it had just received CMS approval for FARAFLEX and believed its supply chain to support the study would be robust by year-end.
• Boston Scientific said FARAFLEX timing was affected by negotiations with the FDA to obtain IDE approval, slight delays with CMS full approval, and operational challenges in completing cases to expand the number of sites.
• Boston Scientific expected FARAFLEX study enrollment to ramp each successive week and month going forward.