Woven's Implantable Fixation Sleeve Gets FDA OK

Ogmend Sleeve provides a solution to hold screws in place.

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Woven Orthopedic Technologies

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 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 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 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."

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