NuVasive's X360 Procedural Approach Validated in Clinical Study Published in The Spine Journal Finding Single-Position Spine Surgery Improves Operative Efficiency While Reducing Complications and Length of Hospital Stay

Rhea-AI Summary

NuVasive, Inc. (NASDAQ: NUVA) announced the results of a comprehensive study published in The Spine Journal, highlighting the advantages of single-position spine surgery. The multi-center study involved 390 patients and compared anterior lumbar interbody fusion (ALIF) and lateral lumbar interbody fusion (LLIF) methods. Key findings showed that single-position lateral surgery (SPLS) significantly reduced operating time by over three hours, lowered blood loss, and shortened hospitalization by an average of two days, while minimizing postoperative complications.

Positive

• Single-position lateral surgery (SPLS) demonstrated over three hours less operating time.
• Reduced average hospital stay by two days compared to traditional surgery.
• Lower postoperative complications, such as intestinal blockage (ileus).
• The study further validates NuVasive's X360 system, enhancing clinical efficiency.
• Improved clinical outcomes noted with >95% fusion rates and up to 90% reduction in blood loss.

Negative

• None.

SAN DIEGO, Jan. 5, 2021 /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced the results of the study, "Single position circumferential fusion improves operative efficiency, reduces complications and length of stay compared with traditional circumferential fusion," in The Spine Journal, validating single-position spine surgery as having significant advantages over traditional, open spinal fusion.

The multi-center, retrospective study included 390 patients who underwent anterior lumbar interbody fusion (ALIF) and/or lateral lumbar interbody fusion (LLIF) surgery with bilateral percutaneous pedicle screw fixation between L2-S1. Two hundred and thirty-seven patients underwent single-position lateral surgery (SPLS) and 153 underwent a "flip" surgery. The study found that SPLS reduced operating time by more than three hours, and led to a reduction in blood loss and intraoperative radiation dosage for the patient. Further, patients who underwent SPLS experienced lower postoperative intestinal blockage (ileus), and their length of stay in the hospital was reduced on average by two days.  

"As an early adopter of the NuVasive X360 system, the clinical benefits and operative efficiency of single-position surgery over traditional surgery, that requires patient repositioning, continue to be proven throughout my practice," said Dr. Aaron Buckland, spine and scoliosis surgeon at Melbourne Orthopaedic Group in Melbourne, Australia. "The results of this study further validate that this practice-changing technique leads to clear benefits for the patient, surgeon and provider."

The results of this study build upon other clinical evidence validating X360®, NuVasive's comprehensive approach to lateral single-position surgery that combines XLIF®, XALIF™ and XFixation™ and is clinically proven to provide better outcomes over traditional open spinal fusion, including:

• Improved clinical outcomes with >95 percent fusion¹ rates and up to 90 percent reduction in blood loss;¹
• Reduced operative time by up to 60 minutes,² resulting in less time under anesthesia and 50 percent shorter length of stay in the hospital;³ and
• Enhanced economics with up to a 20 percent increase in case volumes⁴ and as much as $5,000 saved per patient in hospital costs.^11,12

"Clinical results of the X360 surgical system reiterate NuVasive's proceduralization strategy that enables surgeons to be more efficient in the operating room and deliver better clinical outcomes for their patients," said Massimo Calafiore, executive vice president, Global Business Units at NuVasive. "Further, it affirms the Company's continued focus on using data and research to inform its surgeon training and education on the X360 system that will serve as a key growth driver for the company in 2021 and beyond." 

Product Specific Information
For information about the U.S. Food and Drug Administration cleared labeling for the NuVasive medical devices studied and reported upon in The Spine Journal article entitled "Single position circumferential fusion improves operative efficiency, reduces complications and length of stay compared with traditional circumferential fusion," please visit www.nuvasive.com/resources/electronic-ifu-information. NuVasive devices are only indicated for use with autograft and allograft, and in some instances in the study, were implanted in conjunction with Medtronic's Infuse bone morphogenetic protein (BMP).

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, with a mission to transform surgery, advance care, and change lives. The Company's less invasive, procedurally integrated surgical solutions are designed to deliver reproducible and clinically proven outcomes. The Company's comprehensive procedural portfolio includes access, implants and fixation systems, biologics, software 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 net sales, NuVasive has approximately 2,800 employees and operates in more than 50 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com. 

Forward-Looking Statements
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.

¹Lehmen JA, Gerber EJ. MIS lateral spine surgery: a systematic literature review of complications, outcomes, and economics. Eur Spine J 2015;24(Suppl 3):S287-313.
²Drazin D, Kim TT, Johnson JP. Simultaneous lateral interbody fusion and posterior percutaneous instrumentation: early experience and technical considerations. Biomed Res Int 2015:Article ID 458284.
³Lucio JC, VanConia RB, DeLuzio KJ, et al. Economics of less invasive spinal surgery: an analysis of hospital cost differences between open and minimally invasive instrumented spinal fusion procedures during the perioperative period. Risk Manag Healthc Policy 2012;5:65-74.
⁴Rodgers WB, Gerber EJ, Rodgers JAK. MIS v open spine surgery: the impact on a surgeon's efficiency. Society of Lateral Access Surgery (SOLAS®) 2010 annual meeting. San Diego, CA.
⁵Macario A. What does one minute of operating room time cost? J Clin Anesth 2010;22(4):233-6.
⁶Shippert RD. A study of time-dependent operating room fees and how to save $100,000 by using time-saving products. Am J Cosmet Surg 2005;22(1):25-34.

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SOURCE NuVasive, Inc.

FAQ

What does the study published in The Spine Journal reveal about NuVasive's X360 system?

The study validates that the single-position spine surgery using NuVasive's X360 system improves operative efficiency, reduces complications, and decreases the length of hospital stay compared to traditional methods.

How many patients were involved in the NuVasive study?

The multi-center study included 390 patients who underwent either anterior lumbar interbody fusion or lateral lumbar interbody fusion.

What are the benefits of single-position lateral surgery as per the study findings?

The benefits include reduced operating time by over three hours, lower blood loss, a decrease in hospitalization length by two days, and fewer postoperative complications.

How does the single-position surgery compare to traditional circumferential fusion?

The study indicates that single-position surgery leads to significant improvements in efficiency and patient outcomes compared to traditional circumferential fusion.

What implications do the study results have for the market impact of NuVasive?

The validation of the X360 system and its clinical advantages may drive demand for NuVasive's products, potentially leading to increased sales and market share.