BD Initiates STANCE Trial for GalaFLEX LITE Scaffold in Breast Revision Surgeries

Becton, Dickinson and Company (BD) has enrolled the first subject in its STANCE trial, a randomized, multi-center study evaluating the use of GalaFLEX LITE Scaffold in breast revision surgeries to reduce capsular contracture (CC) recurrence.

Trial & Device Overview:

• FDA Premarket Approval (PMA) Goal: This investigational device exemption (IDE) trial aims to secure FDA approval for the first breast indication of GalaFLEX LITE Scaffold.
• GalaFLEX LITE Scaffold Features:
• Made from fully absorbable poly-4-hydroxybutyrate (P4HB).
• Conforms to anatomical structures for wound healing support.
• Study Details:
• Enrolling 250+ patients at 40 sites.
• Comparing breast revision surgery outcomes with and without GalaFLEX LITE Scaffold.
• Assessing efficacy and safety in reducing CC recurrence.

Capsular Contracture & Need for Innovation

CC is a common complication of implant-based breast surgeries, causing scar tissue hardening, pain, and implant displacement. Severe cases require surgical correction, highlighting the need for advanced supportive solutions like GalaFLEX LITE Scaffold.

This milestone reinforces BD’s commitment to enhancing surgical outcomes through innovative, patient-focused technologies.

22-03-2025

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