FDA ISSUES CLEARANCE FOR WOVEN ORTHOPEDIC'S SIMPLE SOLUTION TO MASSIVE, UNSPOKEN CHALLENGE IN ORTHOPEDIC SPINE SURGERY
MANCHESTER, Conn., March 16, 2023 /PRNewswire/ -- Woven Orthopedic Technologies, developer of an implantable sleeve to aid screw fixation in challenging scenarios, announced today that its Ogmend® Implant Enhancement System has received 510(k) clearance from the Food and Drug Administration (FDA) for use in spine surgery.
"We are thrilled to deliver surgeons a simple, reliable solution to help overcome one of the most prevalent yet least discussed challenges in orthopedic and spine surgery: the ability to more confidently use surgical screws when operating in compromised fixation scenarios," explained Woven Orthopedics' Co-founder and President, Brandon Bendes.
In orthopedic surgery, surgeons position bones to promote proper healing, and more than a billion screws are implanted each year to securely hold those positions in place during the healing process. However, surgeons routinely face scenarios that make it difficult to achieve secure fixation between screws and bone. In those situations, the Ogmend® Sleeve provides a simple, fast, off-the-shelf solution to hold screws in place. It can be deployed in less than 2 minutes and is used with a wide range of screw systems from a variety of suppliers. It's very similar to anchors used in construction to secure screws in fragile plaster and drywall.
"This is game changing," said Dr. Frank Cammisa, Jr., Chief Emeritus of Spine at the Hospital for Special Surgery. "A large, growing percentage of my patients have conditions that make it difficult to ahieve strong fixation. Ogmend® gives me a very simple way to manage these patients and generate the fixation needed to ensure great outcomes. My colleagues and I are looking forward to having this available in the U.S."
The concept for Ogmend® was invented by Dr. Alexander Jones, a long-serving orthopedic and spine surgeon in the U.S. Navy and Kaiser Permanente Health System. Ogmend® was studied clinically at the esteemed Nottingham University Hospitals system in the United Kingdom and is cleared under CE Mark for use in Spine surgery. Recently, it eclipsed the 2,500 unit milestone in Europe.
"It [Ogmend®] has helped us substantially in our practice" says Prof Dr. Bronek Boszczyk, Head of Spine Surgery at Orthopädische Kinderklinik Aschau in Germany. "After participating in the clinical study, I began using Ogmend® in my practice and introduced it to many of my peers in Europe who now use it too. I believe this will become a standard tool in spine surgery."
Ogmend® will be made available in the US through a staged, regional release. Given strong initial demand, the company created a priority waiting list for those interested in receiving units. Providers and partners who would like Ogmend® for use in their practice can visit www.wovenorthopedics.com/reserveus to reserve a position on the priority list.
For more information, visit www.wovenorthopedics.com or contact [email protected]
About Woven Orthopedic Technologies
Woven Orthopedic Technologies is a commercial stage medical device company focused on making neuromusculoskeletal treatments easier, better, and more affordable for surgeons and global health systems. The company is based in Manchester, Connecticut USA.
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SOURCE Woven Orthopedics