US medical technology company Surgical Innovation Associates (SIA) has secured CE Mark approval for its absorbable mesh, called DuraSorb.
The mesh offers mechanical support and scaffolding during the early months of wound healing and scar formation. It is gradually absorbed into the body in one year, leaving the patient free of foreign material.
The CE mark approval enables DuraSorb to be used for reconstructive and aesthetic purposes, including abdominal hernia prophylaxis, breast tissue support, and prosthetic breast support.
SIA noted that its technology adds great value in European hospital systems, as it offers a vital alternative to biologic meshes or permanent synthetic meshes.
Surgeons often try to avoid permanent mesh products, while human or animal-based biologic meshes are generally scarce due to safety concerns and high costs.
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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.”
SIA’s absorbable mesh has been designed by surgeons, textile experts and polymer scientists.
It received initial 510(k) clearance from the Food and Drug Administration (FDA) for soft tissue support in 2018. Last year, the product was used clinically within a post-market registry.
The company began the US commercial efforts for DuraSorb earlier this year.
Currently, no mesh product has approval from the US FDA for any breast procedure.