NuVasive Secures FDA Clearance of MAGEC System Implantation Using Reline Posterior Fixation System

NuVasive Inc. has received U.S. Food and Drug Administration (FDA) a510(k) clearance for its MAGEC system to be surgically implanted using the Reline posterior fixation system for treating patients with severe spinal deformity conditions.
 
The company’s MAGEC system is the only magnetically controlled growing-rod system cleared by the FDA for pediatric spinal deformity. MAGEC helps surgeons reduce the number of planned surgeries required to effectively treat patients with early onset acoliosis (EOS). Supported by the versatility of the Reline system, NuVasive now offers surgeons a solution for treating the most difficult spinal deformities.
 
“The FDA 510(k) clearance is a key milestone for NuVasive as we continue to deliver new innovation to the spine market, and now more specifically, the pediatric deformity market. More importantly, it reflects an increased ability to better treat children with EOS. Combining the innovation of MAGEC and the versatility of Reline, we help transform the experience for these young patients. NuVasive is committed to partnering with surgeons to revolutionize deformity surgery for patients in need around the globe,” said Jason Hannon, NuVasive’s president and chief operating officer.
 
Sonia Garcia, a 6-year-old patient suffering from EOS and severe kyphosis, was identified by Shriners International to need urgent spinal deformity correction surgery. Dr. Robert H. Cho, chief of staff and a leading pediatric orthopedic surgeon at Shriners Hospitals for Children – Los Angeles (California), accepted the case.
 
“When I first met Sonia, she had a poor chance of surviving past her late teens. Because of her severe scoliosis, her quality of life was declining secondary to her lungs becoming collapsed and constricted by her progressive spinal curvature. Leveraging the versatility and reliability of Reline with the innovative MAGEC rod, we have significantly impacted Sonia’s life and minimized the number of surgeries she will require in the future. Immediately following her surgery, Sonia’s lung capacity increased by more than 30 percent, she reclaimed 10 cm of height and her future is bright. This is why I do what I do, to help improve and change lives,” said Cho.
 
Sonia’s mother, Sonia Rafaela Garcia Navarro, said, “I was willing to do whatever it took to find help for my daughter. As a single mother in a remote village in Mexico, we had exhausted our options, and were without hope. However, thanks to Dr. Cho and his clinical staff, Shriners Hospital and NuVasive, I’m speechless. Sonia’s best days are ahead.”
 
NuVasive’s minimally invasive, procedurally-integrated solutions feature a portfolio of spinal deformity technologies, supporting pediatric, adolescent and adult deformities. NuVasive has helped diversify the treatment of adult deformity with the Reline system, Integrated Global Alignment platform (iGA), Anterior Lumber Interbody Fusion (ALIF) and eXtreme Lateral Interbody Fusion (XLIF) Anterior Column Realignment (ACR) systems. Details of the two technologies from the company’s deformity portfolio that Cho leveraged to successfully treat Sonia include:
 

• MAGEC is comprised of a single-use spinal rod that is surgically implanted to brace the spine during growth and includes a small internal magnet controlled by an external remote controller. Periodic lengthening of the rod is performed in an office setting where the surgeon externally controls the implant, eliminating the need for a series of distraction surgeries used in the traditional surgical treatment for young patients.
• The Reline portfolio reflects an evolution of posterior fixation technology, and is integrated with the iGA platform to treat patients through traditional open or minimally-invasive procedures. Whether preserving or restoring spinal alignment, Reline’s single system addresses the spectrum of spinal pathologies from adult degenerative and deformity to specialized pediatric deformity.

 
NuVasive develops minimally invasive, procedurally-integrated spine treatment solutions. NuVasive’s highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $811 million in revenues (2015), NuVasive has an approximate 1,900 person workforce in more than 40 countries around the world.
 
Shriners Hospitals for Children provides pediatric specialty care, research and medical education. Its 22 locations in the United States, Canada, and Mexico provide advanced care for children with orthopedic conditions, burns, spinal cord injuries, and cleft lip and palate. Generally, care is provided until age 18, although, in some cases, it may be extended to age 21.