Integra LifeSciences Announces Complete Enrollment in DuraSorb® Monofilament Mesh U.S. IDE Study
PRINCETON, N.J., June 28, 2023 (GLOBE NEWSWIRE) -- Integra LifeSciences Holding Corporation (Nasdaq:IART), a leading global medical technology company, announced the completion of patient enrollment in the DuraSorb U.S. investigational device exemption (IDE) clinical study for two-stage breast reconstruction.
- PRINCETON, N.J., June 28, 2023 (GLOBE NEWSWIRE) -- Integra LifeSciences Holding Corporation (Nasdaq:IART), a leading global medical technology company, announced the completion of patient enrollment in the DuraSorb U.S. investigational device exemption (IDE) 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.
- 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.