Surgical Innovation Associates, (SIA) an early growth-stage medical technology company, announced today that the first patient has been enrolled in a pivotal trial of its flagship absorbable mesh, DuraSorb, under an investigational device exemption (IDE) from the United States Food and Drug Administration (US FDA).
Surgical Innovation Associates notes the study will evaluate the safety and effectiveness of DuraSorb for reinforcement in prosthetic breast reconstruction.
The product is made from a biocompatible synthetic material to provide mechanical support and scaffolding during the early months of wound healing and scar formation, followed by gradual absorption, which is generally complete by one year.1-4 While DuraSorb® received a CE mark for reconstructive and aesthetic breast surgery last year, no mesh product, DuraSorb or otherwise, currently has approval from the US FDA for breast reconstruction. Despite this, prosthetic breast reconstruction is most often performed with costly biologic mesh derived from the skin of human cadavers.5-7 DuraSorb® is designed to provide the same type of support during breast reconstruction, without requiring any cadaveric or animal-derived tissue.
“As plastic surgeons, we have been using processed human skin in breast surgery for over 15 years,” said Dr. Mihye Choi, an Associate Professor at New York University Hansjorg Wyss Department of Plastic Surgery, and the first principal investigator to enroll a patient in SIA’s pivotal study. “ADM has its benefits, but I am excited to use a non-biologic alternative that has been evaluated by the FDA for this specific purpose.”
The importance of this work is recognized by the National Cancer Institute, which is partially funding the clinical trial through the Small Business Innovation Research Program. In addition, the IDE study was approved by the Centers for Medicare and Medicaid, which will allow Medicare beneficiaries access to the trial.
“After years of collaborative work with FDA on a study design, we are honored to initiate this trial with some leading minds in the field of plastic surgery,” said Dr. Alexei Mlodinow, President and CEO of Surgical Innovation Associates. “This work will move the field forward, with important implications for a population of women who are going through enough as it is following a diagnosis of breast cancer and the need for a mastectomy.”
