Integra LifeSciences
(Nasdaq: IART)
announced that it completed enrollment ints U.S. DuraSorb trial.
The FDA investigational device exemption (IDE) clinical study evaluates DuraSorb in two-stage breast reconstruction. The bioabsorbable matrix-based monofilament mesh currently has FDA clearance to reinforce soft tissue where weakness exists.
Princeton, New Jersey-based Integra said its study marks the first and only active, multi-center IDE study evaluating the use of a surgical matrix in two-stage breast reconstruction. It enrolled several hundred patients across seven major academic hospitals around the U.S. Integra noted in a news release that it completed enrollment “sooner than anticipated.”
The company aims to evaluate the safety and effectiveness of DuraSorb to obtain premarket approval for use in two-stage breast reconstruction. Its primary follow-up period comes one year after device implantation.
DuraSorb is developed, marketed and sold by Surgical Innovation Associates, which is now a subsidiary of Integra LifeSciences. The company acquired SIA in a deal worth up to $140 million in December 2022. SIA operates as a business of the Tissue Technologies division at Integra.
Commentary from Integra officials and trial investigators
Dr. Yoon S. Chun, principal investigator, called the completion of enrollment “exciting,” adding that the clinical research could have a significant impact on the ongoing work for women undergoing reconstructive breast surgery. Chun serves as section chief, division of plastic and reconstructive surgery at Brigham and Women’s Faulkner Hospital in Boston.
“This is a significant milestone on our pathway to a PMA for DuraSorb,” said Todd Cruikshank, VP and GM of SIA. “We look forward to continuing to work with the study investigators to maintain high patient follow-up. 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.”
According to Integra, no FDA-approved surgical matrices exist for implant-based breast reconstruction (IBBR). Integra remains the only company actively progressing toward PMA for such an offering, it said. The company also submitted a PMA application for its SurgiMend PRS surgical matrix for soft tissue support in IBBR. Integra remains on track to file a PMA update for SurgiMend PRS in August.
“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., EVP and president of Integra’s Tissue Technologies division. “Achieving these important 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.”
