NuVasive Specialized Orthopedics Expands Indications of Precice Limb Lengthening System to Treat Pediatric Patients

Rhea-AI Summary

NuVasive, Inc. (NASDAQ: NUVA) announced on March 20, 2023, that it received 510(k) clearance from the FDA for its Precice limb lengthening solution to include pediatric patients. This expansion allows the innovative technology to benefit a broader patient demographic. The Precice system, which has been successfully implanted in over 15,000 cases globally, is designed to non-invasively lengthen limbs and reduce the need for further surgeries. With more than 100 peer-reviewed studies supporting its effectiveness, the new indication is critical for pediatric orthopedic practices, enhancing treatment options for those with limb length discrepancies.

Positive

• 510(k) clearance from the FDA for Precice system to include pediatric patients expands market reach.
• Precice system has been implanted over 15,000 times globally, indicating strong acceptance and usage.
• The technology reduces the need for additional surgeries, enhancing patient care.

Negative

• None.

SAN DIEGO, March 20, 2023 /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the use of its Precice all-internal limb lengthening solution to include pediatric patients*. The expanded clearance extends the clinical benefits of Precice to a wider range of patients.

"Everyone faced with limb length discrepancy (LLD), especially pediatric patients, should have access to a non-invasive limb lengthening solution," said Pete Ligotti, leader of NuVasive Specialized Orthopedics (NSO). "Backed by more than 100 peer-reviewed studies, the difference with Precice is that it accommodates the changing clinical needs of patients as they heal, grow, and age, reducing the need for further surgeries¹ throughout treatment."

Precice is a magnetically adjustable technology that utilizes an external remote to non-invasively lengthen implants. The Precice nail has been implanted more than 15,000 times, by more than 2,000 surgeons, and in nearly 50 countries. As a division of NuVasive, NSO is focused on the design and innovation of disruptive orthopedic solutions for complex orthopedic reconstruction and limb lengthening.

"Precice has over a decade's worth of clinical data and has truly changed the standard of care for my patients," said Dr. John Herzenberg, director of pediatric orthopedics at Sinai Hospital. "This new indication is significant for my practice as the majority of my patients are under the age of 18, and it provides me with the assurance I need to offer Precice as a pediatric LLD solution."

Furthering the Company's ability to treat the full continuum of care, the next phase of NSO's orthopedic innovation is intelligent surgery. The Company's asset acquisition efforts in December 2022 position NSO as an early player in next-generation motorized technology for dynamic orthopedic implants.

*The Precice IMLL System is indicated for limb lengthening of the femur and tibia in pediatric patients (greater than 12 years old).

1. Richardson, S, Schairer W, Fragomen A, et al. Cost Comparison of Femoral Distraction Osteogenesis With External Lengthening Over a Nail Versus Internal Magnetic Lengthening Nail. J Am Acad Orthop Surg 2019 May 1;27(9):e430-36.

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 surgical access instruments, spinal implants, fixation systems, biologics, software for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative neuromonitoring technology and service offerings. With more than $1 billion in net sales, NuVasive 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 and hospitals, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive's products, the Company's ability to adequately 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 recent FDA clearance did NuVasive receive for its Precice system?

NuVasive received 510(k) clearance from the FDA to expand the indications of its Precice limb lengthening system to include pediatric patients.

What are the clinical benefits of NuVasive's Precice system?

The Precice system offers non-invasive limb lengthening and reduces the need for additional surgeries, benefiting patients with limb length discrepancies.

How many times has the Precice system been implanted?

The Precice system has been implanted more than 15,000 times by over 2,000 surgeons in nearly 50 countries.

When was the FDA clearance for the Precice system announced?

The FDA clearance for the Precice system was announced on March 20, 2023.

What is the significance of the new indication for the Precice system?

The new indication is significant as it allows the Precice system to be used for pediatric patients, providing them with a critical treatment option for limb length discrepancies.