Spine Unit of DePuy Synthes Showcases New Technology at NASS

The 28th annual meeting of the North American Spine Society (NASS) was a busy one for Raynham, Mass.-based DePuy Synthes Spine.

First off, the company expanded its collaboration with Brainlab through the worldwide launch of navigation-ready instrumentation for its spine systems, and an exclusive global agreement to co-market the Airo Mobile Intraoperative CT by Brainlab.

Following 510(k) clearance from the U.S. Food and Drug Administration (FDA), Brainlab is moving forward with the sale of the Airo Mobile Intraoperative CT. The FDA clearance was received on Sept. 26 by Mobius Imaging LLC, the developer and manufacturer of Airo Mobile Intraoperative CT.

Brainlab develops software-driven medical technology designed for less-invasive treatment. Core products are image-guided systems and software that provide real-time information used for surgical navigation and radiosurgical planning and delivery. Founded in 2008, Ayer, Mass.-based Mobius Imaging develops and manufactures advanced imaging technologies. The Airo Mobile Intraoperative CT System is the company’s first commercial product and is distributed under an exclusive sales and service agreement with Brainlab.

DePuy Synthes Spine showcased the Airo Mobile Intraoperative CT alongside the full release of navigation-ready instrumentation for its Viper 2 and Expendium Spine Systems. The instrumentation was specially designed to be pre-calibrated for use with Brainlab Navigation Systems, including Curve Image Guided Surgery and Kick Surgical Navigation.

“The broader collaboration between DePuy Synthes Spine and Brainlab will enable us to provide a seamlessly integrated solution of implants, instrumentation and navigation systems that have the potential to improve patient outcomes, inform decision making during surgery, increase efficiency of spinal procedures and reduce O.R. time,” said Max Reinhardt, worldwide president, DePuy Synthes Spine.

DePuy Synthes Spine and Germany-based Brainlab also will continue to collaborate on initiatives to bring spinal navigation solutions to a wider range of surgeons and hospitals throughout the world so that more patients can benefit from image-guided spine surgery.

Brainlab Navigation Systems continuously track surgical instruments in relation to patient anatomy, helping surgeons avoid critical structures, accurately find pedicle entry, screw insertion points and trajectories, and securely place spinal implants.

The company launched the new Synflate Vertebral Balloon as part of its portfolio of procedural solutions for the treatment of painful vertebral compression fractures, internal breaks in spinal bones that commonly occur in people with osteoporosis. According to the American Academy of Orthopaedic Surgeons, more than 700,000 people suffer these types of fractures each year.

The Synflate Vertebral Balloon is semi-elastic with material stiffness that, according to the company, has been optimized to enhance the structural stability of the balloon during inflation, enabling controlled and predictable cavity creation. At maximum inflation volume, the Synflate Vertebral Balloon is nearly double the strength of standard elastic balloons currently available on the market, company officials claim.

The Synflate Vertebral Balloon is available in 10, 15 and 20 millimeters, is offered with mono or bilateral access kits, multiple access trocars, and can be used with bone fillers including DePuy’s Vertecem II and Confidence line of cements.

“The Synflate Vertebral Balloon offers a versatility not found in other vertebral body augmentation portfolios,” said Reinhardt. “The access kits accommodate different physician preferences and surgical approaches, and the multiple balloon sizes enable selection based on specific patient anatomy.”

Vertebral body balloon procedures are used to reduce pain and strengthen and restore the shape and height of collapsed vertebra. In the procedure, the balloon is inserted into the vertebra and inflated to attempt to restore normal bone height. The balloon is then removed and the space or cavity that was created by the inflation of the balloon is filled with special bone cement to strengthen and stabilize the bone.

“DePuy Synthes Spine has created a portfolio of procedural solutions for the treatment of vertebral compression fractures that enables physicians greater choice and flexibility to use whichever products and procedures they determine are best for an individual patient, because no two fractures are alike,” added Reinhardt.

DePuy Synthes Spine develops products for spinal disorders including adult and adolescent deformity, spinal stenosis, trauma and degenerative disc disease. DePuy Synthes Spine is part of the DePuy Synthes Companies of Johnson & Johnson.