After a tumultuous year for its MAGEC line of spinal curve-correcting magnetic rod systems, NuVasive has resumed shipping of the latest version of the system, even as the company works with the FDA to continue investigating safety issues associated with the device.
The FDA issued a notice on July 15 alerting patients and healthcare providers of the potential risks of the MAGEC rods. Chief among these is the long-standing issue of the rods’ endcaps separating from the rest of the device, potentially exposing patients to internal components of the rod that have not been fully tested for biocompatibility.
NuVasive is currently evaluating the biocompatibility of these components to ensure they won’t cause local reactions when exposed to living tissue, and the FDA is, in turn, evaluating the results of those tests.
Even with these evaluations still ongoing, however, the agency said in its notice that the most recently cleared MAGEC Model X rod remains available for implantation, as “the FDA believes the benefits of a MAGEC device outweigh the risks for U.S. patients based on the current FDA-cleared indications for use and labeling.”
The spinal implants are indicated for use in patients under the age of 10 who have developed or are at risk of developing thoracic insufficiency syndrome, a condition often caused by scoliosis in which the chest walls can’t support normal breathing.
In the two years after the MAGEC system is implanted, surgeons can continually adjust the magnetic rods using an external remote controller, reducing the need for repeated operations.
NuVasive first took action to address the safety issues in early 2020, when it issued a recall of the MAGEC systems in response to reports of endcap separations. In the February safety notice, the company noted that the issue occurred in approximately 0.5% of the implanted devices and that its root cause was still under investigation.
The FDA ultimately gave the recall its mid-level Class II label, indicating the possibility of temporary or fully treatable reactions to the device in question, and only a remote risk of severe reactions. Several months later, in July 2020, the agency cleared an updated version of the MAGEC Model X, which was designed to mitigate the endcap separation issue.
Despite the update, by the beginning of 2021, the FDA had begun receiving complaints of local tissue reactions potentially related to the endcap separations. In April, NuVasive instated a global ship hold on all versions of the spinal rod system. In the meantime, the company advised against removing already implanted devices before their scheduled end date; the MAGEC system is cleared to be implanted for only two years in the U.S., and for up to six years in the E.U.
It wasn’t until this month that NuVasive lifted the ship hold in the U.S. In a letter to surgeons, the company said the decision had been made in conjunction with the FDA based on preliminary results of the biocompatibility testing. NuVasive also announced in the letter that it would be discontinuing all versions of the system except the updated edition of the Model X.
In the FDA’s July 15 notice, the agency said it supported the decision to resume implants of the MAGEC system for a variety of reasons, including NuVasive’s decision to distribute only the newest version of the Model X, equipped with an updated label discussing its potential risks. Additionally, per the FDA, the U.S.’s two-year implantation period mitigates many of the risks of long-term use.
As biocompatibility testing continues, the FDA advised providers and caregivers to monitor any unexpected back pain, inflammation or deformities in MAGEC patients—performing X-rays to check on the device’s condition, if necessary—and immediately report any adverse events to the agency.
In the meantime, NuVasive is also currently evaluating biocompatibility concerns associated with its Precice devices for limb lengthening.
A July 8 safety notice from the FDA advised providers that the stainless steel versions of the devices have been completely removed from the market due to health risks caused by wear and tear of the products, and the titanium iterations are currently on a ship hold while the company assesses whether those corrosion issues also affect the titanium devices.