NuVasive (NUVA) and the International Spine Study Group Foundation Announce Expanded Long-Term Partnership with Initiation of Additional Clinical Studies
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NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, and the International Spine Study Group Foundation (ISSGF) today announced the continuation of their long-term partnership through the launch of two new clinical studies focused on improving patient outcomes in adult spinal deformity surgery.
"NuVasive is excited to extend our partnership with the ISSGF, the premier study group on adult spinal deformity, and to support these breakthrough studies that will inform the future of spine care," said Kyle Malone, vice president of clinical, medical, and regulatory affairs at NuVasive. "This partnership reflects NuVasive's dedication to developing outcome driven innovation through clinical validation for surgeons, providers, and patients."
The NuVasive and ISSGF partnership began in 2015 with a five-year, prospective study to compare the clinical, radiographic, and health-related quality of life outcomes between minimally invasive and open techniques in the treatment of adult spinal deformity. Initial reports from the ongoing study show that minimally invasive surgery (MIS) is a feasible and effective approach for treating adult spinal deformity. Based on this foundation, NuVasive and the ISSGF have expanded their partnership to include two additional clinical studies:
- a 10-year, prospective study evaluating complex adult spinal deformity treated with MIS, including comprehensive clinical and radiographic outcomes, and is now expanded to also include measures of physiology and laboratory data; and
- a prospective, case-controlled analysis of the safety profile, clinical and radiographic outcomes, and implant performance of the NuVasive VersaTie® posterior fixation system used in long posterior spinal fusion constructs for adult patients.
"Our partnership with NuVasive represents a collaborative commitment to better understand the pathology and treatment of adult spinal deformity. Together, we will partner on one of the largest and most granular prospective studies on adult deformity ever performed," said Shay Bess, M.D., president of the ISSGF and orthopedic spine surgeon at Denver International Spine Center in Denver, Colorado. "This study gives us the opportunity to compare data to traditional open surgery, with the goal of informing better surgeon decision making to improve patient care and outcomes."
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