Enhancing clinical data
19-004 is an ongoing clinical study conducted in some of the top medical centers in the U.S. The study investigates the use of DuraSorb® to support a tissue expander in two-stage breast reconstruction using both dual plane and pre-pectoral techniques.
The study is supported by a grant from the National Cancer Institute and is the first-of-its-kind to be approved by the U.S. FDA under an Investigational Device Exemption (IDE).
On-label observational study
SIA 19-002 is an ongoing post-market registry study of DuraSorb in various soft tissue support procedures in general and plastic surgery. Over a dozen academic and private-practice surgeons using DuraSorb across the U.S. are building a database of real-world evidence for this next-generation bioabsorbable mesh. Presented at the American Society of Plastic Surgeons’ PSTM in 2019
Biomechanical and Histologic Evaluation of a Novel Absorbable Mesh in a Porcine Model of Abdominal Wall Repair. Presented at Plastic Surgery Research Council 2019