The CE mark allows to use DuraSorb monofilament mesh for reconstructive and aesthetic indications
Medical technology company Surgical Innovation Associates (SIA) has secured CE mark approval for its DuraSorb absorbable mesh.
DuraSorb is a monofilament mesh designed to deliver mechanical support and scaffolding during the early months of wound healing and scar formation. By gradual absorption, the DuraSorb will make the patient free from foreign material in one year.
The approval enables to use DuraSorb for reconstructive and aesthetic indications, comprising abdominal hernia prophylaxis, breast tissue support, and prosthetic breast support.
DuraSorb serves as an alternative to biologic meshes or permanent synthetic meshes
DuraSorb, which has been designed by surgeons, textile experts, and polymer scientists, is a next-generation product in a category of bioabsorbable materials and serves as an alternative to biologic meshes or permanent synthetic meshes.
At the end of 2018, the company secured 510(k) clearance from the US Food and Drug Administration (FDA) for DuraSorb for soft tissue support. In 2019, the DuraSorb was first used within a post-market registry.
According to the company, no mesh product, including DuraSorb, currently has approval from the FDA for any breast procedure.
SIA president and CEO Dr Alexei Mlodinow said: “It is important that we expand access to our products for plastic and reconstructive surgeons and their patients beyond our own borders here in the US.
“We are excited to work with one of several potential partners across the pond to introduce DuraSorb in Europe and, in the future, other markets.”
In August this year, Deep Blue Medical Advances obtained the US Food and Drug Administration (FDA) 510(k) approval for its T-Line Hernia Mesh with integrated suture-like extensions.