BD (Becton, Dickinson and Company) announced that its STANCE clinical trial evaluating GalaFLEX LITE™ Scaffold in breast revision surgery for capsular contracture has reached its first enrollment milestone, with 274 patients treated across 33 active U.S. sites, triggering the first planned interim analysis. This enrollment surpasses 50% of the trial's maximum planned enrollment, which is expected to range from 250 to 530 patients under the adaptive design. Capsular contracture, the most frequent complication of implant-based breast surgery, has an overall incidence of 10% to 20%, and recurrence risk may be as high as 54% with conventional techniques. The study aims to support an FDA Premarket Approval application for a breast indication for GalaFLEX LITE™ Scaffold, which is composed of poly-4-hydroxybutyrate (P4HB), a bioabsorbable polymer with over 10 years of clinical use in soft tissue support.
Becton Dickinson and CompanySTANCE trial for GalaFLEX LITE Scaffold reached first enrollment milestone, advancing toward an FDA PMA breast indication.
Intuitive Surgical Inc