NASS News: CTL Amedica Unveils Horizontally Expandable MI Interbody Implant

CTL Amedica Corporation is unveiling its RODIN Transforaminal Expandable Lumbar Interbody Fusion System during the North American Spine Society (NASS) annual meeting and exhibition this week in Boston (through Oct. 2). 
 
U.S. Food and Drug Administration-cleared and in beta launch at CTL Amedica, RODIN is a horizontally expandable, minimally invasive interbody implant made of titanium. It has superior biomechanics, surface area and graft volume capacity, all with a simplified delivery system. At a 6mm cross-sectional width, non-deployed, it offers one of the smallest collapsed footprints of any expandable on the market. With its horizontally expanding capabilities, convex surfaces and lordotic offerings, the RODIN accomplishes a stable and impressive ALIF footprint through an MIS posterior approach.
 
“RODIN represents evidenced-based, superior clinical results that surgeons and patients demand,” said Dr. Fabian. “RODIN is designed to accommodate a wide range of patient anatomies and surgical preferences. Using RODIN, the surgeon can accomplish an ALIF footprint through an MIS posterior approach, which gives the surgeon all the biomechanical advantages of the ALIF—anterior column support, better mechanics, more bone graft volume, more surface area and higher fusion rates—all without the need to go anterior, and we have the outcome data to prove it.” 
 
CTL Amedica will launch RODIN with a long term (> 10-year follow-up) clinical series with a 98.5 percent clinical and radiographic fusion rate and an animal study showing 100 percent fusion throughout the entire series, with post study CT scan and histologic confirmation. Product designer Henry F. Fabian Jr., M.D., MBA, has implanted the product in multiple surgeries with excellent results. 
 
A skilled spine surgeon, Fabian has been in private practice for a number of years and has served as the team physician for several prominent organizations, including the U.S. Ski Association Men’s Alpine Ski Team, Steamboat Springs Winter Sports Club, Cleveland Crunch National Pro Soccer League and Cleveland Lumberjacks IHL Pro League. Fabian earned a bachelor’s degree in biomedical engineering from Case Western Reserve University, a master’s degree in biomedical engineering from Ohio State, a medical degree from the Medical College of Ohio and an executive MBA from Ohio State. He also completed an internship in general surgery and a residency in orthopedic surgery at St. Luke’s Medical Center; as well as a fellowship in adult and pediatric reconstructive spine surgery at The Colorado Spine Center/Rocky Mountain Spine Clinic and an international training fellowship in internal fixation at Medizinische Hochschule Hannover Unfall Klinik in Hannover, Germany.
 
CTL Amedica is a medical device design, development, and manufacturing company. CTL Amedica maintains a Texas-based headquarters and in-house manufacturing facility, along with a Pennsylvania-based R&D Center of Excellence. A leader in the medical device technology and biomaterials space, CTL Amedica provides a full line of cervical, thoracic and lumbar fusion and fixation products. In addition, it is the world’s exclusive provider of silicon nitride spine products. Silicon nitride demonstrates unique bacteriostatic properties, provides superior imaging across all modalities and promotes an enhanced osteogenic response.