Binder Gets FDA OK for Anterior Lumbar Fixation System
Surgeons treating patients with degenerative disc disease now may use a new standalone intervertebral body fusion device recently cleared by the U.S. Food and Drug Administration (FDA). Manufactured by Binder Biomedical Inc., the device is an anterior lumbar fixation system with what the company touts as a "simple, one-step locking mechanism."
Called Logic, the system is designed for use in a direct anterior surgical approach for accessing the intervertebral disc space of the patient's lumbar spine. The limited release is planned by the first quarter of 2014. The nationwide launch is expected by the fourth quarter of 2014, according to the company.
"Our design team has done a great job putting together such a comprehensive system, ensuring that it can be tailored to any surgeon's preferred surgical technique," said Binder Biomedical President Lawrence Binder.
According to the company, each implant is designed with a large central window for optimum autograft bone placement. Size offerings range from 10 to 20 millimeters in height, and all devices have an anatomically shaped lordotic angle that matches the convex curvature of the vertebral endplates. The Logic devices are implanted into the intervertebral space and then three screws are placed through the device, into the vertebrae to provide stabilization and facilitate fusion.
The design team leader is Mark Testaiuti, M.D., a spine neurosurgeon at Coastal Spine, in Mt. Laurel, N.J.
"Working with the Binder team on the Logic system," Testaiuti said, "has been a rewarding and satisfying experience. Their responsiveness and attention to detail separates Binder from other companies I have worked with."
The system is manufactured using PEEK-Optima polymer from Invibio Biomaterial Solutions, with which Binder Biomedical has a long-term supply assurance agreement.
The devices are manufactured in FDA-registered facilities in the United States.
Team member Peter Whang, M.D., an associate professor in the Department of Orthopedics, at Yale University School of Medicine, said: "Rather than being content with the industry standard," he said, "we have created a truly innovative system that reflects our lengthy collective experience as surgeons and engineers. Together, we have created a world-class system that meets all of our needs while maintaining ease of use."
Logic is indicated for stand-alone intervertebral body fusion in patients with degenerative disc disease, confirmed by radiographic studies, at one or two contiguous levels of the lumbosacral spine (L2-S1).
Miami, Fla.-based Binder Biomedical is privately held.