First-class soft tissue support products will soon be launched in Europe for abdominal wall, cosmetic and breast reconstruction surgery
DuraSorb ® Monofilament Screen (Photo: Business Wire)
DuraSorb ® Monofilament Screen (Photo: Business Wire)
CHICAGO--(BUSINESS WIRE)--Surgical Innovation Associates (SIA), an early-growth medical technology company, today announced that its flagship resorbable mesh DuraSorb® has received CE mark approval. The product provides mechanical support and scaffolding during the first few months of wound healing and scar formation, and then gradually absorbs so that the patient is free of foreign bodies within one year. 1,2,3
DuraSorb® received the CE mark for reconstruction and aesthetic indications, including prevention of abdominal hernia, breast tissue support, and prosthetic breast support. This technology has added tremendous value to the European hospital system. Surgeons sometimes try to avoid using permanent mesh products, while bionets based on humans or animals are scarce due to safety issues and high costs. Currently, no mesh products, DuraSorb or other products have been approved by the U.S. Food and Drug Administration (FDA) for any breast surgery.
Dr. Alexei Mlodinow, President and CEO of SIA, said: "It is important that we allow plastic and reconstructive surgeons and their patients to use our products outside the United States. This is very important." One of two potential partners will collaborate to launch DuraSorb® in Europe and in other markets in the future."
Designed by surgeons, textile experts, and polymer scientists, DuraSorb® is the next-generation product in an increasing number of bioabsorbable material categories and an important alternative to bionets or permanent synthetic nets. The product obtained the initial 510(k) soft tissue support license from the U.S. FDA at the end of 2018, and was used for clinical use in post-marketing registration for the first time in 2019. Earlier this year, the United States began a commercial effort.
After on-site assessment by LNE/G-MED, an international organization that supervises the quality of medical device manufacturing, SIA's quality management system has also passed the ISO 13485:2016 certification. These certificates confirm the company's focus on customer needs and its commitment to the highest product quality standards and international regulatory compliance.
Todd Cruikshank, Chief Operating Officer of SIA, said: “ISO certification and CE marking represent an important milestone in our transformation from a US R&D organization to a global commercial organization.” This is an important proof that Singapore Airlines has the necessary infrastructure and controls to provide global The patient community designs, produces and distributes high-quality medical equipment. "
About the Surgical Innovation Association (SIA)
SIA was established in Chicago in 2016 and has since advanced the DuraSorb® product line from conception to FDA 510k approval to the operating room. The company plans to continue to research and develop other products and indications for breast reconstruction and facial beauty applications. As with any implantable medical device, the use of DuraSorb® carries the risk of complications, which may be caused by the surgical implantation procedure or the device itself. A complete list of warnings and precautions is provided in the instructions for use by surgeons in the United States and the European Union. In the United States, the device is only approved for soft tissue support and is still being studied for specific applications for breast reconstruction and aesthetics.
Learn more at SIA.health.
Kristof Barron Media@SIA.health +1 (312) 888-3941
First-class soft tissue support products will soon be launched in Europe for abdominal wall, cosmetic and breast reconstruction surgery
Kristof Barron Media@SIA.health +1 (312) 888-3941