CHICAGO--(BUSINESS WIRE)--Surgical Innovation Associates (SIA), an early growth-stage medical technology company, announced today it secured CE Mark approval for its flagship absorbable mesh, DuraSorb®. The product provides 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.1,2,3
DuraSorb® received a CE mark for reconstructive and aesthetic indications including abdominal hernia prophylaxis, breast tissue support, and prosthetic breast support. This technology adds tremendous value in European hospital systems, where surgeons sometimes try to avoid permanent mesh products, and human- or animal-based biologic meshes are scarce due to safety concerns and high costs. No mesh product, DuraSorb or otherwise, currently has approval from the United States Food and Drug Administration (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 US,” said Dr. Alexei Mlodinow, President and CEO of SIA. “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.”
Designed by surgeons, textile experts, and polymer scientists, DuraSorb® is a next-generation product in a growing category of bioabsorbable materials that provide an important alternative to biologic meshes or permanent synthetic meshes. The product received initial 510(k) clearance from the US FDA for soft tissue support in late 2018, and was first used clinically within a post-market registry in 2019. US commercial efforts began earlier this year.
SIA’s quality management system was also certified under ISO 13485:2016, following on-site evaluation by an international body that governs the quality of medical device manufacturing – LNE/G-MED. These certificates confirm the company’s focus on customer needs as well as its commitment to the highest standards of product quality and international regulatory compliance.
“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 Todd Cruikshank, COO of SIA. “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.”
About Surgical Innovation Associates (SIA)
Founded in Chicago in 2016, SIA has since advanced the DuraSorb® product family from ideation through FDA 510k clearance and into the operating room. The company plans to pursue investigation and development of additional products and indications for breast reconstruction and facial aesthetic applications, among others. Use of DuraSorb®, like any implantable medical device, carries risk of complications that may arise from the surgical implantation procedure or from the device itself. A full list of Warnings and Precautions is available in the Instructions for Use documents for US and EU surgeons. In the United States, the device has been cleared only for soft tissue support and remains investigational for specific applications in breast reconstruction and aesthetics.
Learn more at SIA.health.
References:
- Clinical data on file. Study 19-002: Real-World Application of Durasorb™ Monofilament Mesh: An Open-Label Registry Study of Soft Tissue Support in General and Plastic Surgery.
- Mlodinow A.S., Kuzycz M., Hasse M., Cruikshank T., Wiegel S.W., & Vazquez R. (October, 2018). Proof-of-Concept Use of Novel Biosynthetic Scaffold in a Porcine Model of Abdominal Wall Repair Oral Presentation presented at: American College of Surgeons Congress 2018; Boston, MA, USA.
- Mlodinow AS, Kuzycz M, Hasse M, Cruikshank T, Wiegel SW, Ellis MF, & Kim JYS. (May, 2019). Biomechanical and Histologic Evaluation of a Novel Absorbable Mesh in a Porcine Model of Abdominal Wall Repair. Poster presented at: Plastic Surgery Research Council 2019; Baltimore, MD, USA.
