Becton, Dickinson and Company (BD) has treated the first subject in the randomised multi-centre STANCE trial with GalaFLEX LITE Scaffold for reducing the recurrence of capsular contracture (CC) during breast revision surgeries.
This investigational device exemption (IDE) trial is a crucial step toward obtaining premarket approval (PMA) from the US Food and Drug Administration (FDA).
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BD Surgery business worldwide president Rian Seger said: “This milestone marks a significant advancement in our efforts to achieve FDA premarket approval for our first breast indication for GalaFLEX LITE Scaffold and reinforces the company’s commitment to improving patient outcomes through innovative technologies that reduce surgical complications.
“Our team has worked closely with the FDA to help address a critical medical complication arising from implant-based breast surgery, and the first patient treated brings us closer to delivering a much-needed solution.”
BD noted that the GalaFLEX LITE Scaffold is made from a fully absorbable, biologically derived polymer known as poly-4-hydroxybutyrate (P4HB), and is designed to “conform” to the required anatomical structure and offer support during the healing process of the wound.
The prospective, controlled study anticipates enrolling a minimum of 250 subjects across 40 investigative sites.
It will compare the outcomes of patients undergoing breast revision surgery with GalaFLEX LITE Scaffold to those receiving conventional surgery without the use of supportive matrices.
It will also evaluate the efficacy and safety of the device in breast implant revision surgery for treating CC.
CC is a common complication of implant-based breast surgeries. In this condition, scar tissue that develops naturally surrounding the implant hardens and leads to pain and anatomical displacement, with advanced cases requiring surgical intervention.
In December 2024, BD and Babson Diagnostics broadened the usage of their fingertip blood collection alongside testing technologies across US health systems and several ambulatory care settings.
