Integra completes enrollment inDuraSorb U.S. IDE study for breast reconstruction

Integra LifeSciences Holding announced the completion of patient enrollment in the DuraSorb U.S. investigational device exemption clinical study for two-stage breast reconstruction. DuraSorb Monofilament Mesh is a bioabsorbable matrix currently 510 K cleared for the reinforcement of soft tissue where weakness exists. The DuraSorb IDE study, which is 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 academic hospitals across the country sooner than anticipated. The purpose of this study is to evaluate the safety and effectiveness of DuraSorb to obtain pre-market approval 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, Mass. “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.”