News: NuVasive Receives FDA 510(k) Clearance Reinforcing Comprehensive Portfolio Supporting Pediatric, Adolescent and Adult Spinal Deformity Patients
Innovative NuVasive Spinal Deformity Technology Helps Leading Shriners Hospitals for Children -- Los Angeles Surgeon in Treating Six-Year-Old With Early Onset Scoliosis and Severe Kyphosis
SAN DIEGO, CA--(Marketwired - September 19, 2016) - NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced it has received FDA 510(k) clearance for the Company's market-leading MAGEC® system to be surgically implanted using its 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 Scoliosis (EOS). Supported by the versatility of the Reline system, NuVasive now offers surgeons a comprehensive 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 game-changing 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 six-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, 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 10cm of height and her future is bright. This is why I do what I do, to help improve and change lives," said Dr. Cho.
Sonia's mother, Sonia Rafaela Garcia Navarro, shared, "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 full portfolio of market-leading spinal deformity technologies, supporting pediatric, adolescent and adult deformities. NuVasive has a rich history of revolutionizing 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 comprehensive deformity portfolio that Dr. 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.
Attendees of the 51st Annual Scoliosis Research Society annual meeting in Prague, Czech Republic will have the opportunity to learn more about the MAGEC system, as guest speakers David Marks and Dr. Sulken Shah discuss best practices on September 22 at 4:30 p.m. in the Corinthia Hotel Prague.
NuVasive, Inc. (NASDAQ: NUVA) is a world leader in minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, NuVasive is transforming spine surgery with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. 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. For more information, please visit www.nuvasive.com.
About Shriners Hospitals for Children
Shriners Hospitals for Children is changing lives every day through innovative pediatric specialty care, world-class research and outstanding medical education. Our 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. All services are provided in a compassionate family-centered environment. For more information, please visitwww.shrinershospitalsforchildren.org/losangeles.
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive's results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company's surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive's products (including the iGA™ platform), the Company's ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive's news releases and periodic filings with the Securities and Exchange Commission. NuVasive's public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.