Latest clearance unites RELINE® Small Stature fixation portfolio with the MAGEC@ System and introduces a new design with 5.0 millimeter rod to be unveiled at Scoliosis Research Society 52nd Annual Meeting
San Diego, CA /PRNewswire/ - NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use of the Company's redesigned MAGEC® system with its RELINE® Small Stature system. NuVasive will feature these new product offerings at the Scoliosis Research Society (SRS) 52nd Annual Meeting & Course to be held September 6-9, 2017 in Philadelphia.
The MAGEC system uses innovative magnetic technology within adjustable growing rods to treat early-onset scoliosis in a less invasive manner. The latest advancements to the MAGEC system include redesigned components to help provide ease-of-use for the surgeon and help make surgical outcomes more reproducible. In addition, the MAGEC system is introducing a new 5.0 millimeter rod diameter offering, that when paired with the low-profile RELINE Small Stature system, is designed to provide optimal strength to growing-rod constructs to help improve clinical outcomes.
RELINE Small Stature is a comprehensive pediatric deformity fixation system allowing to achieve optimal construct strength with a reduced implant profile. RELINE Small Stature is the only small stature system that is compatible with the new 5.0 millimeter MAGEC rod.
"As a low-profile pediatric fixation system, RELINE Small Stature is the first-of-its-kind system to offer competitively-sized pediatric implants that accept up to a 5.0mm rod," said Matt Link, executive vice president of strategy, technology and corporate development at NuVasive. "The clearance for our redesigned MAGEC system with RELINE Small Stature highlights our speed to market and our further commitment to bringing procedural solutions that transform care to the pediatric deformity market."
NuVasive has reached meaningful gains in both the adult and pediatric deformity markets, a $2.5 billion opportunity over the last two years and is a leading sponsor of SRS. The Company's 'Embracing the Journey Together' initiative includes pediatric spinal deformity research, education and spinal deformity event support, assisting leading surgeons as they educate other surgeons around the world.
NuVasive will showcase its market-leading, procedurally-integrated technologies in Meeting Room #406 at the Philadelphia Marriot Downtown. Visit here for more details.
NuVasive, Inc. (NASDAQ: NUVA) is transforming spine surgery and beyond with minimally invasive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company's portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries serving surgeons, hospitals and patients. 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.
SOURCE: NuVasive, Inc.