ApiFix surpasses 250 scoliosis patients and 6-year follow-up of earliest patients
ApiFix Ltd., a leading motion-preservation scoliosis correction company, announced today that its patented Minimally Invasive Deformity Correction (MID-C) technology has now been used to treat more than 250 young patients diagnosed with progressive scoliosis. The company also announced that the earliest treated patients have reached their six-year follow-up milestone.
ApiFix’s MID-C technology is a posterior dynamic deformity correction system that enables surgeons to perform a unique treatment providing permanent curve correction while retaining spine flexibility using a least invasive surgical approach. Patient recovery is relatively pain-free and is measured in days, not months. The MID-C system acts as an “internal brace” that incorporates a patented unidirectional, self-adjusting rod mechanism with motion-preserving polyaxial joints allowing additional non-invasive post-operative correction over time and is removable.
The MID-C device has been used for treatment in multiple countries, with more than 100 patients now having greater than two-year follow-up. A typical ApiFix surgical procedure takes about 90 minutes with minimal blood loss (~50cc) and short hospitalization and recovery times (1-2 days and 1-2 weeks, respectively). In contrast to fusion correction procedures, the MID-C system allows for additional deformity correction with standard post-operative exercises. Patients’ normal daily activities are unencumbered since spine flexibility and mobility are retained.
Available treatment options for progressive scoliosis in the U.S. have been limited despite continued advances in both surgical and non-surgical systems – a perspective shared by Randy Betz, MD, past president of the Scoliosis Research Society.
“Despite great recent advancements, our options to address progressive curvature in young patients today remain limited,” said Dr. Betz. “Bracing systems are required to be worn many hours per day and do not correct the deformity. Standard spinal fusions correct the deformity but have a much longer recovery time and result in a permanent loss of mobility. The introduction of a procedure that can effectively correct spinal deformity with less invasive, motion-preserving techniques will have a dramatic effect on the quality of life for these patients and their families.”
“The new ApiFix surgery is much less invasive than standard fusion procedures, allowing for a significantly shorter recovery,” said Ron El-Hawary, MD, Chief of Orthopedics, IWK Health Centre in Halifax, Canada, who has been impressed with his use of the MID-C device in patients. “We see that patients have more flexibility and they will likely have better participation in sports, dance and other activities performing at the same level or higher than previously. Based on my own experience and the overall early experience of many patients beyond two-years follow-up, I believe this device has great promise in offering a completely different option for adolescent idiopathic scoliosis patients with progressive curves.”
Paul Mraz, ApiFix CEO, is committed to establishing a new standard of care for spinal deformity treatment, generating peer-reviewed evidence, and working with the FDA to help make this new technology available for patients in the United States. The device is currently investigational in the United States and is under review by FDA in a Humanitarian Device Exemption application.
“Our review of the extensive clinical experience with the MID-C system and our ongoing collection of new data continue to underscore ApiFix’s positive results realized in patients with progressive spinal deformity,” said Mraz. “ApiFix represents a game-changing opportunity for patients and families and a viable alternative to irreversible fusion procedures. We look forward to making this technology more widely available worldwide.”