Enrollment Completed in DuraSorb Monofilament Mesh Study

Integra LifeSciences Holding Corporation has finished enrolling patients in the DuraSorb U.S. investigational device exemption (IDE) clinical study for two-stage breast reconstruction. DuraSorb Monofilament Mesh is a bioabsorbable matrix currently cleared by the U.S. Food and Drug Administration (FDA) for reinforcing soft tissue where weakness exists.
 
The DuraSorb IDE study, the first and only active, prospective, multi-center IDE study in the U.S. evaluating the use of a surgical matrix in two-stage breast reconstruction, has enrolled several hundred patients from seven major U.S. academic hospitals sooner than anticipated. The study will evaluate the safety and effectiveness of DuraSorb to obtain pre-market approval (PMA) for use in patients undergoing two-stage breast reconstruction. The primary follow-up period is one year after device implantation.
 
“It is very exciting to see the completion of the DuraSorb arm enrollment for this important prospective multi-center study as well as the dedication of the medical professional teams across the study sites,” said Dr. Yoon S. Chun, principal investigator and section chief, division of plastic and reconstructive surgery at Brigham and Women’s Faulkner Hospital in Boston. “I look forward to completing this clinical research which will have a significant impact on our ongoing work to set new standards of care and achieve the highest quality outcomes for women undergoing reconstructive breast surgery.”
 
“This is a significant milestone on our pathway to a PMA for DuraSorb. We look forward to continuing to work with the study investigators to maintain high patient follow-up,” said Todd Cruikshank, vice president and general manager of Surgical Innovation Associates (SIA), a business of the Tissue Technologies division at Integra. “We are grateful to the investigators and patients enrolled in this study which is intended to help advance women’s health and improve patient outcomes following breast cancer and mastectomy.”
 
There currently are no FDA-approved surgical matrices for implant-based breast reconstruction (IBBR). Integra remains the only company actively progressing toward PMAs for surgical matrices in breast reconstruction. In addition to the ongoing DuraSorb U.S. IDE study, Integra was the first manufacturer to submit a PMA application with SurgiMend PRS, a surgical matrix for use as soft tissue support in IBBR. 

“Integra’s SurgiMend PRS, together with DuraSorb, will enable us to provide surgeons with two distinct soft tissue reinforcement solutions, which aim to address various clinical, contracting, and economic needs across more sites of care,” added Robert T. Davis Jr., executive vice president and president of Integra’s Tissue Technologies division. “Achieving these PMA milestones reinforces our commitment to our implant-based breast reconstruction strategy, innovating new treatment pathways, and restoring patient lives through technologies that transform surgical care.”
 
Integra LifeSciences offers a portfolio of brands that include AmnioExcel, Aurora, Bactiseal, BioD, CerebroFlo, CereLink Certas Plus, Codman, CUSA, Cytal, DuraGen, DuraSeal, DuraSorb, Gentrix, ICP Express, Integra, Licox, MAYFIELD, MediHoney, MicroFrance, MicroMatrix, NeuraGen, NeuraWrap, PriMatrix, SurgiMend, TCC-EZ, and VersaTru.