Medical device start-up Surgical Innovation Assets said yesterday it won FDA 510(k) clearance for its DuraSorb monofilament mesh, designed for reconstructive and cosmetic surgery.
The newly cleared DuraSorb mesh is the first from a line of advanced bioresorbable technologies, the Chicago-based company said. The DuraSorb is intended to integrate into the patient’s tissue to provide support during the initial phases of healing, then completely dissolve over time.
Surgical Innovation Associates said it plans to release the DuraSorb in select locations early next year.
“The idea of a mesh that is there when you need it and gone when you don’t is appealing, for much the same reason that absorbable sutures have become a key part of a surgeon’s armamentarium – tissue support from a foreign material is crucial during healing, but at some point thereafter may become a liability. This technology was developed in direct response to unmet clinical needs in our field,” device inventor Dr. John Kim of Northwestern University said in a prepared statement.
“Having known people who have gone through the pain of multiple mesh-related operations, I found it gratifying to collaborate closely with opinion-leading surgeons to make DuraSorbTM a reality. Their guidance went into every key decision during product development, and will now steer our clinical trial strategy as we replicate our robust preclinical data in a real-world setting,” SIA CEO Alexei Mlodinow said in a press release.
