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. |