NuVasive Enrolls First Patients in Study Evaluating Advanced Spinal Implants Used in XLIF Procedures

NuVasive Inc., developer of spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, has enrolled the 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 (polyether ether ketone) 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 United States. 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 is hosting several clinical workshops and podium presentations this week during the North American Spine Society (NASS) Annual Meeting in Los Angeles, Calif., (booth No. 2301). 

NuVasive Inc. develops spine technology that attempts to transform 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.