SAN DIEGO, CA--(Marketwired - October 27, 2016) - NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced FDA clearance for magnetic resonance imaging (MRI) under certain conditions on patients treated with the innovative MAGEC® system. MAGEC is the only noninvasive solution for growth modulation in pediatric spinal deformity cleared by the FDA.
Early onset scoliosis (EOS) patients often suffer from comorbidities which makes their treatment complex and often requires them to undergo multiple MRIs. The lack of guidance on MR conditions was historically a hurdle for some surgeons in widely adopting MAGEC as a treatment option for their EOS patients.
"Having clear, defined guidance for conditional MRI compatibility with MAGEC helps alleviate uncertainty that may have limited surgeons from using the innovative MAGEC system," said Suken A. Shah, M.D., Division Chief of the Spine and Scoliosis Center, Clinical Fellowship Director, Nemours/Alfred I. duPont Hospital for Children. "This clearance opens up the door for more patients and their families to benefit from this life changing technology."
The clearance includes MR conditions using a 1.5 Tesla (T) Static Magnetic Field MRI machine at a maximum spatial field gradient of 3000 gauss/cm (30 T/m) with a maximum MR System reported, whole body averaged specific absorption rate (SAR) of 0.5 W/kg at 1.5T. Under the scan conditions defined, the MAGEC System is expected to produce a maximum temperature rise of no more than 3.7 degrees Celsius after 15 minutes of continuous scanning. The 1.5 T MRI machine is the global standard. The complete MRI safety information is included in the product labeling.
"As the only noninvasive growth modulation system on the market, this clearance is a key milestone in overcoming a known barrier in the treatment of children with EOS," said Jason Hannon, NuVasive's president and chief operating officer. "NuVasive is consistently on the cutting-edge of the latest treatment options and we work diligently to bring that innovation to as many patients as possible around the world."
MAGEC is comprised of a sterile, single use spinal rod that is surgically implanted to brace the spine during growth and includes a small internal magnet that is controlled by an external remote controller. Periodic lengthening of the rod is performed to follow the growth of the spine, and can be performed external to the body in an office setting. The magnetic technology helps eliminate traditional planned distraction surgeries and simplifies care for the EOS patient population.
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 2,200 person workforce in more than 40 countries around the world. For more information, please visit www.nuvasive.com.
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.