News: NuVasive Receives First Ever FDA 510(k) Clearance of Cervical Corpectomy Cage
SAN DIEGO, CA--(Marketwired - October 12, 2015) - NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, announced today the first ever FDA 510(k) clearance of a cervical corpectomy cage. The X-Core® Mini Cervical Corpectomy System is an expandable titanium vertebral body replacement device designed to provide enhanced stability following a corpectomy procedure. This first-of-its kind clearance further showcases NuVasive's commitment to investing in innovative technology and clinical research to improve patient outcomes.
The NuVasive X-Core Mini Cervical Expandable VBR System (X-Core Mini VBR) is a vertebral body replacement device indicated for use in the cervical spine (C3-C7 vertebral bodies) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture or osteomyelitis, in addition to the reconstruction following a corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. X-Core Mini VBR is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine. These implants are intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. It is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
"The X-Core Mini system allows the surgeon a choice of endcaps and core diameters, ensuring each construct is optimized to best address each patient's individual surgical needs," said Dr. Neill Wright, a neurosurgeon practicing at Barnes Jewish Hospital in St. Louis, MO. "I have used X-Core Mini in degenerative, neoplastic, traumatic, and infectious cases. With so many options of size and endcap, in each case, from the more common single level to the rare five-level corpectomy, the X-Core Mini has fit perfectly and simply. The design of X-Core Mini, from connection of the endcaps to the core, to in-situ expansion, to locking, has proven to be straightforward, reproducible, durable and reliable. The large central channel allows for copious amount of graft material, and the large anterior window allows for augmentation with further graft after insertion and expansion."
X-Core Mini must be used with supplemental fixation cleared by the FDA for use in the cervical spine, which includes NuVasive's newly released Archon® Reconstruction Corpectomy plate. NuVasive is redefining cervical corpectomy surgery as the Archon-R plate is designed to offer improved biomechanical rigidity and resistance to screw pullout when compared to a traditional two-hole plate construct and is a first-of-its kind indication by the FDA as particularly suited for use following corpectomies for the treatment of tumors and burst fractures.
"This assembly of best-in-class cervical products into a cohesive procedural offering further reinforces NuVasive's commitment to providing single-source, integrated procedural solutions to our customers," said Pat Miles, President and Chief Operating Officer of NuVasive. "Combining X-Core Mini VBR and Archon Reconstruction plate provides another excellent example of defining the components necessary to properly address an unmet market need as NuVasive remains focused on becoming number one in spine."
The Archon®Reconstruction system incorporates technology developed by Gary K. Michelson, M.D.
NuVasive is an innovative global medical device company that is changing spine surgery with minimally disruptive surgical products and procedurally-integrated solutions for the spine. NuVasive has emerged from a small startup to become the #3 player in the $9 billion global spine market and remains focused on market share-taking strategies as the Company continues on its path to become the industry's leading spine company. NuVasive offers a comprehensive spine portfolio of more than 90 unique products developed to improve spine surgery and patient outcomes. The Company's principal procedural solution is its Maximum Access Surgery, or MAS®, platform for lateral spine fusion. MAS was designed to provide safer, reproducible, and clinically proven outcomes, and is a highly differentiated solution with fully integrated neuromonitoring, customizable exposure, and a broad offering of application-specific implants and fixation devices designed to address a variety of pathologies.
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.