FDA Clears SIG Medical's AdvantageRib Anterior System
HERSHEY, Pa., Nov. 19, 2018 /PRNewswire/ -- SIG Medical (www.sigmedical.net) announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its AdvantageRib Anterior System, K182179. This product is the second rib fracture system that SIG Medical is commercializing. SIG Medical is now the market leader in offering the most comprehensive portfolio of rib fracture products that are revolutionizing traditional care which left patients immobilized and in pain for months
The comprehensive AdvantageRib Anterior System contains titanium plates and screws to treat rib fractures through a traditional anterior approach. The system features anatomically contoured plates designed to fit patient anatomy, with geometry based on state-of-the-art scientific studies. The system also has highly adaptable straight plates allowing the surgeon to create a construct to fit even the most challenging clinical scenarios. The titanium screws available in the system consist of self-drilling, self-tapping, locking, non-locking, and a length range for all sizes of rib anatomy. The intuitive instrumentation in the set allows for quick implantation while minimizing soft tissue dissection. The AdvantageRib Anterior System is intended for the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.
"We are thrilled to have achieved this approval and now have the most comprehensive portfolio of rib fracture products," said Andrew Davison, VP of Product Development and Marketing at SIG Medical. "The AdvantageRib family of products is truly revolutionary and will change how suffering patients are treated. Surgeons now have choices as to how best to treat their patients, in both a traditional manner or with our novel system that is on the forefront of improving how rib fractures are managed. Today is a huge leap for us and the medical community as a whole."
This approval comes just weeks after SIG Medical announced that it closed its oversubscribed Series Seed funding round. "We have a world class team, working capital, and now the most complete line of products to lead the market in fixing fractured ribs," said Ken Kremer, President and CEO of SIG Medical. "The AdvantageRib family of products will have a significant impact on the algorithm of care for decades to come and I am proud to be part of such an exciting movement."
About SIG Medical
SIG Medical is pioneering rib fixation optimized for the operating room. Our mission is to provide more immediate and definitive patient care: reducing pneumonia, time in intensive care, chronic pain, ventilator support, chest wall deformity, and accelerate patient recovery. We aim to improve patient care and significantly reduce the overall cost to the healthcare system. For more information, visit www.sigmedical.net
Andrew Davison, Vice-President