- Data Show Substantial Decreases in Patient Morbidity, Surgery Time, Hospital Stay and Blood Loss -
SAN DIEGO, July 18 /PRNewswire-FirstCall/ -- NuVasive, Inc. (Nasdaq: NUVA), a medical device company focused on developing products for minimally disruptive surgical treatments for the spine, announced today results from a study conducted by Neill Wright, MD, Assistant Professor of Neurological Surgery at Washington University in St. Louis, on the safety and reproducibility of the Company's XLIF(TM) (eXtreme Lateral Interbody Fusion) minimally disruptive spine surgery procedure.
The XLIF procedure is a technique that allows spine surgeons to achieve a direct lateral approach to the patient's intervertebral disc space through the psoas muscle as compared to more traditional open procedures which utilize an anterior (through the abdomen) or posterior (through the back muscle) approach. Coupled with the Company's NeuroVision(R) Nerve Avoidance System, the MaXcess(R) Retraction System allows for maximum surgical access to the spine for addressing the pathology and inserting an interbody implant. This muscle splitting versus cutting approach minimizes soft tissue dissection and disruption that often occurs during open surgery, and as a result reduces operative time and patient rehabilitation.
Dr. Wright presented the data in a presentation entitled "XLIF -- the United States Experience 2003-4" at the 12th International Meeting on Advanced Spine Techniques (IMAST) conference in Banff, Canada. The study included data from 145 XLIF surgeries performed by 20 U.S. surgeons on patients with varying lumbar spine disorders.
The results showed the XLIF procedure provided safe and effective access to the disc space and resulted in minimal patient morbidity. Specifically, XLIF had an average operative time of 74 minutes, average blood loss of 88 cc, average postoperative ambulation of 7-12 hours and average hospitalization time of 1-2 days.
NuVasive's NeuroVision(R) Nerve Avoidance System proved imperative to the XLIF procedure's safety. The study showed that NeuroVision(R) detected a nerve in or near the approach pathway in 46% of cases reported. Due to nerve detection NuVasive's "smart instrument" was then repositioned with a new trajectory and the disc safely accessed.
The procedures performed in the XLIF study addressed several different lumbar degenerative diagnoses. The procedures, which were mostly single-level treatments, were performed mainly at L4-5 (37%) and L3-4 (33%), extending as high as L1-2 for the remaining 30%. Most patients were repositioned for posterior pedicle screw supplementation, although some received lateral fixation and some were not supplemented.
Alexis V. Lukianov, Chairman and Chief Executive Officer, said, "We are extremely pleased with the results of the first U.S. study of consecutive cases employing our proprietary XLIF procedure compiled by Dr. Wright. The study reinforces our belief that the XLIF procedure, made possible by our MaXcess(TM) Retractor, NeuroVision(R) Nerve Avoidance Systems and specialized implants, offers a safe and reproducible minimally disruptive approach to lumbar spine fusion surgery. After over 1,000 cases, we continue to receive very positive feedback on the XLIF approach from spine surgeons and momentum in the adoption of the procedure remains robust."
NuVasive is a medical device company focused on the design, development and marketing of products for the surgical treatment of spine disorders. The Company's product portfolio is focused on applications in the over $2 billion U.S. spine fusion market. The Company's current principal product offering includes a minimally disruptive surgical platform called Maximum Access Surgery, or MAS(TM), as well as classic fusion implants.
The MAS platform offers advantages for both patients and surgeons such as reduced surgery and hospitalization time and faster recovery. MAS combines three categories of current product offerings -- NeuroVision(R), a proprietary software-driven nerve avoidance system; MaXcess(R), a unique split-blade design retraction system; and specialized implants, like SpheRx(TM) and CoRoent(TM) -- that collectively minimize soft tissue disruption during spine surgery while allowing maximum visualization and surgical reproducibility. NuVasive's classic fusion portfolio is comprised predominantly of proprietary saline packaged bone allografts and internal fixation products. NuVasive also has a robust R&D pipeline emphasizing both MAS and motion preservation products such as Total Disc Replacement (TDR).
NuVasive cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements 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. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements. The potential risks and uncertainties that could cause actual growth and results to differ materially include, but are not limited to, risks that additional clinical experience may demonstrate that our products or proprietary procedures do not provide the intended safe and reproducible results, the rapidly changing and competitive nature of the medical device industry, NuVasive's ability to convince surgeons to use its products, the ability of patients to obtain third-party reimbursement for surgical procedures employing NuVasive's products, risks related to NuVasive's ability to effectively manage the growth of its business, NuVasive's ability to successfully develop new products, and other risks and uncertainties more fully described in NuVasive's press releases and periodic filings with the Securities and Exchange Commission. NuVasive's public filings with the Securities and Exchange Commission are available at http://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.
Contact: Investors: Kevin C. O'Boyle Stephanie Carrington/Nick Laudico EVP & Chief Financial Officer The Ruth Group NuVasive, Inc. 646-536-7017/7030 858-909-1800 firstname.lastname@example.org email@example.com firstname.lastname@example.org