NuVasive this week announced it received FDA 510(k) clearance for the use of its Precice all-internal limb lengthening solution for pediatric patients.
Precice is a magnetically adjustable technology that uses an external remote to non-invasively lengthen implants. The system’s nail has been implanted more than 15,000 times by more than 2,000 surgeons.
“Precice has over a decade’s worth of clinical data and has truly changed the standard of care for my patients,” Dr. John Herzenberg, director of pediatric orthopedics at Sinai Hospital, said in a news release. “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.”
The company plans to further its ability to treat the full continuum of care with intelligent surgery.
“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. “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 surgeries throughout treatment.”