Woven Orthopedic Technologies has announced that its Ogmend implant enhancement system has received 510(k) clearance from the US Food and Drug Administration (FDA) for use in spine surgery.
Brandon Bendes, Woven Orthopedic’s co-founder and president, said: “We are thrilled to deliver surgeons a simple, reliable solution to help overcome one of the most prevalent yet least discussed challenges in orthopaedic and spine surgery: the ability to more confidently use surgical screws when operating in compromised fixation scenarios.”
The Ogmend sleeve provides a simple, fast, off-the-shelf solution to hold screws in place, say Woven Orthopedics. It can be deployed in less than two minutes and is used with a wide range of screw systems from a variety of suppliers. It is very similar to anchors used in construction to secure screws in fragile plaster and drywall, the company adds.
Frank Cammisa, Jr, chief emeritus of spine at the Hospital for Special Surgery (New York, USA), added: “This is game changing. A large, growing percentage of my patients have conditions that make it difficult to achieve 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 USA.”
The concept for Ogmend was invented by Alexander Jones, a long-serving orthopaedic and spine surgeon in the US Navy and Kaiser Permanente Health System. Ogmend was studied clinically at Nottingham University Hospitals system in the UK and is cleared under CE Mark for use in spine surgery.
Bronek Boszczyk, head of spine surgery at Orthopädische Kinderklinik Aschau (Aschau im Chiemgau, Germany), commented: “It [Ogmend] has helped us substantially in our practice. 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.”