Dive Brief:
- The U.S. Food and Drug Administration has written to healthcare providers to emphasize its current indications and instructions for use of NuVasive’s limb-lengthening system.
- NuVasive paused shipments of its Precice devices for lengthening limbs in 2021 but resumed the sale of some products later that year after showing that its titanium-based devices may be free of the problems associated with stainless steel implants.
- The FDA said it continues to monitor the safety of the titanium implants and, having expanded the use of the devices to children in a recent 510(k) clearance, is reminding healthcare providers of its position on the products.
Dive Insight:
The FDA in March gave 510(k) clearance to NuVasive to market its Precice Intramedullary Limb Lengthening System for use in the femur and tibia of children aged 12 years and up. Having lowered the minimum age for using the device, the FDA wrote to healthcare professionals to ensure the product is used properly in both children and the original adult population.
NuVasive cited the return of its Precice titanium devices to international markets as a driver of the 11% growth it reported outside the U.S. in the fourth quarter. The following quarter, the company named the pediatric 510(k) clearance as a “key milestone” that positions the business for long-term growth.
In its letter to providers, the FDA said it is not aware of reports of adverse events related to biocompatibility issues with titanium-based Precice devices.
“As NuVasive continues to investigate the root cause of issues with stainless steel-based Precice devices, the company is also looking into how those issues may relate to titanium-based devices,” the FDA stated.
The FDA asked healthcare professionals to read and follow the instructions for use, and listed the indications in which Precice devices can be used in adults and children. The agency noted that NuVasive’s Precice Freedom and Unyte devices can only be used in people aged 18 years and up.
Precice devices cannot be used in people under 50 pounds or over the maximum patient weight described in the product’s instructions and must be removed after one year. Up to two devices can be implanted in a patient at the same time.
These restrictions were in place prior to the publication of the letter to healthcare professionals.