The FDA today informed healthcare providers of potential biocompatibility concerns with Precice devices from NuVasive (NSDQ:NUVA).
Precice devices are implants for those 18 years of age and older and are used to lengthen the limb, shorten or compress the limb or transport segments of long bones. They include adjustable rods that are placed inside a patient and are driven by an internal magnetic mechanism.
According to an FDA notice, there have been reports describing pain and changes in surrounding bone and soft tissue in patients with the stainless steel-based Precice devices. The adverse events could be related to corrosion, wear and previously unanticipated exposure of components that are undergoing biocompatibility testing.
NuVasive posted a statement on April 5 to inform healthcare providers of ongoing testing with Precice devices, placing a global ship hold for all of them.
The FDA noted that, at this time, it remains uncertain if the root cause is related to the stainless steel material or related to design features and materials common to all Precice devices.
As of now, the FDA is not aware of adverse events related to biocompatibility issues with titanium-based Precice devices, although it said NuVasive continues to investigate the root cause of the issues with an eye on how they may relate to titanium-based devices.
NuVasive’s stainless steel-based Precice devices include the Precice Bone Transport, the Precice Plate and the Precice Stryde. The titanium-based devices include the Precice Freedom, the Precice Intra-medullary Limb Lengthening device, the Precice Short and the Precice Unyte.
The company is currently performing additional biocompatibility testing on materials used for all Precice devices against updated standards.
A NuVasive spokesperson issued the following statement to MassDevice via email:
“This latest communication from the U.S. FDA reinforces previous company communication to our customers. NuVasive continues to work diligently with the U.S. FDA and global regulatory bodies to provide the requested information and/or satisfy regulatory requirements and is confident in our action plan in place to make these products available for patients as soon as possible. Please refer to the company’s statement on the NuVasive website for further details: https://www.nuvasive.com/