Healthcare Industry News: lumbar interbody fusion device
News Release - April 11, 2019
Nuvasive Advances Lateral Single-Position Surgery With Introduction Of X360(TM) System At AANS 2019Integrated Procedural System Advances Approach to Minimally Invasive Surgery
SAN DIEGO, April 11, 2019 -- (Healthcare Sales & Marketing Network) -- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced it will introduce the X360™ system integrated with Pulse™ for lateral single-position surgery at the American Association of Neurological Surgeons (AANS) Annual Scientific Meeting being held April 13–17, 2019 in San Diego, California.
The X360 system is the most comprehensive approach to lateral single-position surgery, leveraging advanced techniques and technologies to deliver best-in-class, patient-specific care, while enhancing operating room (OR) workflow and efficiency. Proprietary surgical procedures XLIF®, XALIF™ and XFixation™ are integrated with the Pulse surgical automation platform, enabling a surgeon to perform multiple procedures from the lateral position throughout the entire surgery. As a result of not having to reposition the patient, the X360 approach can reduce up to 60 minutes1 of operating time, therefore reducing the amount of time a patient's under anesthesia and lowering intra-operative risk,2,3 while saving the hospital on average nearly $5,000 per patient.4,5 With the integration of Pulse, surgeons can now use navigation technology to help improve line of sight, ease-of-use and surgical efficiency in spinal fixation surgery.
"X360 has transformed my approach to treating patients, allowing me to customize my surgical workflow, reduce patient anesthesia time, and efficiently treat the patient in a single, lateral position," said Anand Veeravagu, MD, assistant professor of Neurosurgery and assistant professor of Orthopedic Surgery, by courtesy, and director of Minimally Invasive NeuroSpine Surgery at Stanford University Medical Center. "Integrating planning, imaging, navigation, and automation throughout this entire surgical approach has become an integral component to the clinical outcomes of my patients."
NuVasive has been the global leader in lateral spine surgery for more than 15 years, built on the foundation of the Company's XLIF® procedure and supported by extensive clinical evidence with more than 400 peer-reviewed publications. The X360 system extends the Company's lateral single-position surgery approach, helping to accelerate the adoption of minimally invasive surgery (MIS), one of the fastest growing sub-segments in spine. Studies have shown an MIS approach in spine can lead to more predictable outcomes than traditional spinal fusion procedures, with substantially fewer complications6-10 and lower infection rates.11 The X360 system now aligns all of NuVasive's lateral procedures and technologies in one integrated approach enabling surgeons to treat more pathologies and spinal levels from one position. In support of the X360 system, the Company offers enhanced surgeon education programs to drive adoption of MIS techniques among spine, orthopedic and access surgeons.
"The X360 system is the most comprehensive approach to lateral single-position surgery available on the market," said Matt Link, president of NuVasive. "NuVasive continues to extend its global leadership position in lateral surgery with the integration of X360 and Pulse, the only surgical automation platform designed for spine surgery. By incorporating Pulse and, in the future, robotic automation, with X360, we are enhancing the overall OR workflow and helping surgeons deliver greater clinical predictability and reproducible outcomes for their patients."
NuVasive will provide live surgeon-led demonstrations at AANS showcasing the full integration of the X360 system with the Pulse surgical automation platform at booth #1415 between Sunday, April 14 to Tuesday, April 16.
X360 microsite: www.nuvasive.com/solutions/x360
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 more than $1 billion in revenues, NuVasive has approximately 2,600 employees and operates in more than 50 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.
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2. Olsen MA, Mayfield J, Lauryssen C, et al. Risk factors for surgical site infection in spinal surgery. J Neurosurg 2003;98(2):149-55.24.
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8. Khajavi K, Shen A, Lagina M, et al. Comparison of clinical outcomes following minimally invasive lateral interbody fusion stratified by preoperative diagnosis. Eur Spine J 2015;24(3 Suppl):322-30.
9. Okuda S, Miyauchi A, Oda T, et al. Surgical complications of posterior lumbar interbody fusion with total facetectomy in 251 patients. J Neurosurg Spine 2006;4(4):304-9.
10. Scaduto AA, Gamradt SC, Yu WD, et al. Perioperative complications of threaded cylindrical lumbar interbody fusion devices: anterior versus posterior approach. J Spinal Disord Tech 2003;16(6):502-7.
11. Lehmen JA, Gerber EJ. MIS lateral spine surgery: a systematic literature review of complications, outcomes, and economics. Eur Spine J 2015;24(3 Suppl):287-313.
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