BD (Becton, Dickinson and Company) has started an Investigational Device Exemption (IDE) study to evaluate the safety and efficacy of GalaFLEX LITE Scaffold in treating capsular contracture (CC) during breast implant revision surgery.
The randomised, controlled, multi-centre trial, dubbed STANCE, aims to support BD’s Premarket Approval (PMA) application with the US Food and Drug Administration (FDA).
It is designed to compare revision surgery outcomes in patients with implant-based breast augmentation using the scaffold versus conventional revision surgery.
The study will enrol at least 250 patients across 40 investigative sites and are randomised in a 2:1 ration to receive either the scaffold or standard care.
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.”
CC recurrence is a common complication in implant-based breast procedures, where scar tissue around an implant becomes hard, causing pain and anatomical displacement.
The STANCE study evaluates whether the GalaFLEX LITE Scaffold reduces the likelihood of recurrence or malposition.
The GalaFLEX LITE Scaffold is designed to conform to anatomical structures, providing immediate strength and stability during wound healing.
Made from Poly-4-Hydroxybutyrate (P4HB), a fully absorbable, biologically derived polymer, it has over 10 years of clinical use in hernia repair and other soft tissue procedures.
Currently, patient enrolment is underway at HKB Cosmetic Surgery in North Carolina, Billington Plastic Surgery in Florida, and The Practice Plastic Surgery in California.
Other sites include the Plastic Surgery Institute of New York, Newport Plastic and Reconstructive Surgery Associates in California, and Essential Medical Research in Oklahoma.
The study’s National Principal Investigator Caroline Glicksman said: “As an early adopter of the P4HB technology, we are excited to see the potential benefits of GalaFLEX LITE Scaffold in improving patient outcomes in breast revision surgeries.
“This study is crucial in providing the data FDA requires for a specific breast indication that will advance our ability to deliver better solutions for breast surgery patients.”
