BD (Becton, Dickinson and Company) announced on March 20, 2025, the first patient treated in an Investigational Device Exemption (IDE) clinical trial for the use of GalaFLEX LITE™ Scaffold. This trial aims to advance BD's efforts to achieve Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) for decreasing capsular contracture (CC) recurrence during breast revision surgery.
Capsular contracture is the most frequent complication of implant-based breast surgery, with an incidence ranging from 10% to 20%, and recurrence rates as high as 54% with conventional techniques. The multi-center STANCE study is a pivotal trial designed to evaluate whether GalaFLEX LITE™ Scaffold reduces the likelihood of CC and/or malposition.
The trial is expected to enroll at least 250 patients across 40 investigative sites, positioning BD as a leader in advanced biomaterial science. GalaFLEX LITE™ Scaffold is made from P4HB, a fully absorbable, biologically-derived polymer with over 10 years of clinical use in other reconstructive procedures, offering a new solution to a critical medical complication.
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