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NuVasive MaXcess® Retractor Featured in Study Further Validating Prone, Single-Position XLIF® Published in The Journal of Neurosurgery: Spine

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NuVasive, Inc. (NASDAQ: NUVA) announced a study validating the use of its MaXcess® retractor for prone, single-position lateral interbody fusion, published in The Journal of Neurosurgery: Spine.

The study demonstrates successful outcomes in 11 of 12 patients treated, contributing to the evidence supporting this surgical approach. It shows a commitment to innovative spine surgery solutions, highlighting the potential for increased efficiency and reduced operative time while noting some limitations for patient eligibility. The X360™ system's value was also emphasized.

Positive
  • Successful outcomes in 11 of 12 patients treated with prone, single-position lateral interbody fusion.
  • Validation of the MaXcess retractor in a significant clinical study, enhancing the company's credibility.
  • Study supports the potential for increased surgical efficiency and reduced operative time.
Negative
  • One patient could not be treated successfully in the prone position, requiring conversion to a different procedure.

SAN DIEGO, Oct. 5, 2020 /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 prone lateral approach: cadaveric feasibility study and early clinical experience," in The Journal of Neurosurgery: Spine, which features NuVasive's MaXcess® retractor and further validates prone, single-position lateral interbody fusion.  

"As the global leader in lateral spine surgery, NuVasive remains committed to developing comprehensive, procedural solutions that provide a truly patient-specific and optimized surgical outcome," said Massimo Calafiore, senior vice president and general manager of NuVasive's spine business unit. "This study adds to the growing body of evidence validating the NuVasive MaXcess retractor's ability to perform lateral surgery in a variety of approaches, including prone position. Further, it highlights the utility of this approach, as well as its limitations, as not all patients were able to be treated in the prone position, and underscores the value of NuVasive's X360 system—which offers a complete solution for our surgeon partners."

The paper details a two-part study of prone, single-position lateral interbody fusion: the first provides cadaveric feasibility data to the lateral approach with the patient in the prone position, and the second explores the initial clinical experience of prone, single-position lumbar interbody fusion at two centers. A total of eight levels were treated in the cadaveric specimens, without any visceral, vascular or endplate violations noted. In the clinical series, 11 of 12 patients were able to be treated with prone, single-position lateral interbody fusion successfully, with no endplate violations or resultant subsidence. The one patient who could not have a successful prone, single-position lateral interbody fusion was converted to a single-position lateral interbody fusion procedure without incident. This study builds upon previous literature validating the prone position using NuVasive's MaXcess retractor, a key tool in the Company's X360™ system, and represents the largest clinical series published to date describing outcomes of prone position for a lateral approach. The authors concluded that prone positioning, in select patients, is a safe and reproducible alternative that can increase efficiency and decrease operative time.  

"Prone positioning for a lateral approach presents an exciting opportunity for streamlining surgical access to the lumbar spine and facilitating a more efficient surgical solution with potential clinical and economic advantages for certain patients," said Juan Uribe, MD, chief of the division of spinal disorders at Barrow Neurological Institute in Arizona. "As a long time XLIF user, I am grateful for NuVasive's leadership in developing single-position procedural technologies that support a variety of positions and span the entire patient care continuum."

About NuVasive
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 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.

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SOURCE NuVasive, Inc.

FAQ

What does recent study involving NuVasive's MaXcess retractor reveal?

The study validates the use of MaXcess® retractor for prone, single-position lateral interbody fusion, showing successful outcomes in 11 of 12 patients.

What is the significance of the study published in The Journal of Neurosurgery: Spine for NUVA?

This study adds to the evidence supporting NuVasive's innovations in spine surgery, demonstrating the effectiveness of their techniques and tools.

How many patients were treated successfully in the study regarding NUVA?

In the study, 11 out of 12 patients successfully underwent the proposed surgical procedure.

What are the implications of the prone positioning approach in NuVasive's study?

The prone positioning approach may increase efficiency and decrease operative time, offering potential clinical advantages.

NuVasive, Inc.

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