Sam Brusco, Associate Editor03.14.23
Woven Orthopedic Technologies, developer of an implantable sleeve to assist in screw fixation in difficult scenarios, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Ogmend implant enhancement system 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,” Woven Orthopedics’ co-founder and president, Brandon Bendes told the press.
The Ogmend sleeve provides an off-the-shelf solution to hold screws in place. It can be deployed in under two minutes, according to the company, and is used with a range of screw systems from a variety of suppliers. It’s 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.”
Ogmend’s concept 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 Nottingham University Hospitals system in the U.K. and is cleared under CE mark for use in spine surgery. Recently, it passed the 2,500 unit milestone in Europe.
"It [Ogmend] has helped us substantially in our practice,” said 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 U.S. through a staged, regional release.
"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,” Woven Orthopedics’ co-founder and president, Brandon Bendes told the press.
The Ogmend sleeve provides an off-the-shelf solution to hold screws in place. It can be deployed in under two minutes, according to the company, and is used with a range of screw systems from a variety of suppliers. It’s 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.”
Ogmend’s concept 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 Nottingham University Hospitals system in the U.K. and is cleared under CE mark for use in spine surgery. Recently, it passed the 2,500 unit milestone in Europe.
"It [Ogmend] has helped us substantially in our practice,” said 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 U.S. through a staged, regional release.
