#United States #BD #Franklin Lakes #GalaFLEX LITE #capsular contracture

BD's GalaFLEX LITE™ Scaffold Clinical Trial Begins

In a groundbreaking step for the medical technology sector, BD (Becton, Dickinson and Company), a prominent player in the global medical arena, has treated its first patient with the innovative GalaFLEX LITE™ Scaffold as part of an Investigational Device Exemption (IDE) clinical trial. This trial focuses on addressing a common yet significant issue in breast implant surgeries: capsular contracture (CC).

Understanding Capsular Contracture

Capsular contracture is a condition when scar tissue forms around a breast implant, leading to discomfort and visual displacement. This complication affects a notable percentage of patients, with research showing an incidence rate between 10% to 20%. In severe cases, treating CC often necessitates surgical intervention, and current methods present a high recurrence risk— up to 54%.

The STANCE (Study of GalaFLEX LITE™ Poly-4-Hydroxybutyrate (P4HB) Scaffold in Treatment of Capsular Contracture after Breast Implant Augmentation) clinical trial was designed to evaluate the efficacy of the GalaFLEX LITE™ Scaffold in lessening the chances of CC and malposition during breast revision operations. This pivotal research is crucial, as it positions BD at the forefront of biomaterial science, pushing the boundaries of surgical possibilities in reconstructive medicine.

Innovation in Action

Rian Seger, global president of the BD Surgery business, emphasized the importance of this development, stating, “This milestone marks a significant advancement in our efforts to achieve FDA Premarket Approval for our first breast indication. It reinforces our commitment to improving patient outcomes through innovative technologies that reduce surgical complications.”

The scaffold has been thoughtfully engineered to match the desired anatomical structure while providing immediate strength and stability throughout the wound healing process. Made from a fully absorbable and biologically-derived polymer called P4HB, the scaffold has seen over a decade of clinical application in various procedures, indicating its reliability and safety in use.

Dr. Shawna Kleban, the board-certified plastic surgeon who performed the initial procedure, expressed her enthusiasm about participating in the trial. “It’s an opportunity to help identify a concrete solution for capsular contracture, not only for the current patients but for future cases as well.” Dr. Caroline Glicksman, the National Principal Investigator of the study from Sea Girt, New Jersey, reiterated this sentiment: “As an early adopter of P4HB technology, we anticipate that the GalaFLEX LITE Scaffold could vastly improve patient outcomes in breast revision surgeries.”

A Collaborative Approach

Currently, there are five investigational sites enrolling patients for this trial, with plans to include at least 250 participants from approximately 40 locations. The aim is to thoroughly assess the safety and efficacy of the GalaFLEX LITE™ Scaffold compared to conventional revision surgery practices where no supportive matrix or acellular dermal matrix (ADM) is used. Patients participating in this trial will be randomized to either receive the scaffold or have standard care without additional supportive measures.

BD is dedicated to maintaining a high standard of scientific rigor and prioritizing patient safety throughout this trial and beyond. The commitment to proactive FDA engagement is apparent as the company seeks to develop and offer solutions that meaningfully impact women's health.

Conclusion

The launch of the clinical trial for GalaFLEX LITE™ Scaffold represents a significant step towards advancing practices in breast surgery. With ongoing dedication to innovation and patient care, BD aims to deliver transformative solutions that not only enhance surgical procedures but also significantly improve patient quality of life following breast augmentation surgeries.

For more information on BD and their innovative solutions in health care, visit BD's official website or connect on social media platforms including LinkedIn and Instagram.