Surgical Innovation Associates announced this week that it has secured CE Mark approval for its flagship absorbable mesh, DuraSorb.
The product is designed to provide mechanical support and scaffolding during the early months of wound healing and scar formation, followed by gradual absorption to leave the patient free of foreign material by one year, according to the Chicago-based company.
Designed by surgeons, textile experts and polymer scientists, DuraSorb provides an alternative to biologic meshes or permanent synthetic meshes. The product received initial 510(k) clearance from the FDA for soft-tissue support in late 2018, and was first used clinically within a post-market registry in 2019. U.S. commercial efforts began earlier this year.
DuraSorb’s CE mark applies to reconstructive and aesthetic indications including abdominal hernia prophylaxis, breast tissue support and prosthetic breast support. No mesh product, DuraSorb or otherwise, currently has approval from the FDA for any breast procedure.
“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 U.S.,” said Surgical Innovation Associates president & CEO Dr. Alexei Mlodinow in a news release. “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.”
Separately, Surgical Innovation Associates’ quality management system was certified under ISO 13485:2016.
“The ISO certification and CE Mark represent significant milestones in our transition from a US-based R&D organization to a global commercial one,” said company COO Todd Cruikshank. “This is an important demonstration that SIA has the necessary infrastructure and controls to design, produce and distribute high quality medical devices for a global patient population.”
Original Article: (http://feedproxy.google.com/~r/MedicalDesignAndOutsourcing/~3/rW2J3mv2xV4/)
