NuVasive Enrolls First Patients In Long-Term, Controlled Study Evaluating Advanced Implants' Effects On Fusion And Clinical Outcomes In XLIF® Procedures
SAN DIEGO, Sept. 26, 2018 /PRNewswire/ -- NuVasive, Inc. (NASDAQ :NUVA ), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced it enrolled its first patients in a prospective, multicenter study evaluating advanced spinal implants used in XLIF® procedures and their effect on long-term patient outcomes.
This study will evaluate and compare the clinical and radiographic outcomes between traditional smooth PEEK intervertebral spacers and two implants within the NuVasive Advanced Materials Science™ (AMS) portfolio, Modulus® 3D-printed titanium and Cohere® Porous PEEK™, in patients who undergo a one- or two-level XLIF procedure. In addition, within each implant group, randomization between Osteocel® Pro and cancellous allograft chips with bone marrow aspirate will allow for procedural comparisons using Level I biologic outcome evidence. In this two-year follow-up study, at least 10 surgeon investigators will measure the progression of fusion in approximately 300 patients across the U.S. Through the study's results, NuVasive seeks to drive better clinical outcomes for patients, and prove out more efficient and cost-effective procedures for surgeons and hospitals.
The NuVasive AMS portfolio of implants are intelligently designed to deliver enhanced osseointegration and biomechanics through proprietary design and manufacturing methods. This study directly demonstrates the Company's support of high-quality clinical research and evaluating its technologies to further drive innovation and improve quality of care.
"This is one of the most ambitious post-market studies undertaken by a spine company, and NuVasive is proud to partner on this initiative with key opinion leaders at some of the premier institutions in spine," said Kyle Malone, head of Medical Affairs for NuVasive. "This study confirms NuVasive's commitment to cultivating objective insights on implants with surface technology, and this work will provide key comparative, clinical evidence to build out smarter, more reproducible surgical solutions to improve the overall quality of care."
To date, NuVasive has embarked on more than 65-sponsored clinical studies and has more than 500 peer-reviewed papers related to its products and procedures. The Company has also supported more than 100 individual surgeons and institutions with their research and publications, with one of their most recently published studies investigating Porous PEEK in treating degenerative cervical disc disease.
NuVasive will host several clinical workshops and podium presentations during the North American Spine Society (NASS) Annual Meeting, September 26-29, 2018 in Los Angeles, California, and attendees can visit NuVasive's team of experts at Booth #2301 to learn more about its AMS implants and biologics portfolio.
NuVasive, Inc. (NASDAQ :NUVA ) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, 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 over $1 billion in revenues, NuVasive has an approximate 2,400 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.