SAN DIEGO, CA--(Marketwired - September 06, 2016) - NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced a key event in the Company's advancement in the treatment of patients with deformity spinal conditions.
On Monday September 12, Dr. Michael G. Vitale, MD, MPH, Director of Pediatric Orthopedics at Columbia Orthopedics, will use the MAGEC® system to treat a seven-year-old Early Onset Scoliosis (EOS) patient with a progressive 45 degree curve and multiple cardiac comorbidities. The case will be featured in a live surgery event, in partnership with BroadWater's Total Spine Series 2016, hosted by The Spine Hospital at NewYork-Presbyterian.
Dr. Michael Vitale commented, "I am honored to take part in this event to demonstrate the success of the MAGEC system in transforming the lives of pediatric patients requiring surgical treatment for EOS. The live surgery event will demonstrate that the surgical technique is no different from what surgeons have historically done. However, with the elimination of additional planned distraction surgeries, the MAGEC system helps simplify care for this patient population like no other technology."
"NuVasive's technology platform is quickly becoming the standard of care in pediatric deformity. The MAGEC rod can be extended non-invasively with a magnet, significantly reducing the number of planned distraction surgeries from up to 15 surgeries over several years, to a single surgery. By transforming the experience for these young patients, NuVasive is able to help minimize the risks associated with multiple surgeries, while also reducing the total cost of care. We will continue to partner with surgeons like Dr. Vitale to revolutionize deformity surgery with a comprehensive offering for pediatric, adolescent and adult deformity patients," said Gregory T. Lucier, NuVasive's Chairman and Chief Executive Officer.
The simultaneous live surgery broadcast will allow surgeons to observe a live feed, ask real-time Q&A with operating surgeons and take part in afternoon case discussions and lectures. In addition, the live surgery has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (AACME) through the joint sponsorship of Medical Education Resources (MER) and BroadWater, providing a maximum of up to 7 AMA PRA Category 1 credit(s)™. For more information and to register for the event, visit www.broad-water.com.
The MAGEC System
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 externally to distract the spine in an office setting, eliminating distraction surgeries and helping to simplify care.
Earlier this month, the U.S. Centers for Medicare and Medicaid Services (CMS) granted a new technology add-on payment (NTAP) for magnetically controlled growth rods. For a technology to qualify for an NTAP in the inpatient setting, the solution must demonstrate a substantial clinical improvement relative to available alternatives.
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 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.