The stars are re-aligning for NuVasive and its MAGEC spine-straightening system.
Several months after the system’s CE mark was temporarily suspended and NuVasive issued a voluntary global shipping hold on the implants, the devicemaker has been cleared to resume sales in Europe and beyond.
In a field safety notice (PDF) sent to healthcare providers this month, NuVasive announced that the CE mark for the MAGEC system has been reinstated as of Nov. 19—alongside updated instructions for use. The new labeling shortens the prescribed implant time from six years to two years, narrows the definition of the device’s intended use population and includes new sections cautioning healthcare providers about the risk of adverse events and complications associated with extended use of the system.
The system is now indicated only for patients under the age of 10 with severe progressive spinal deformities who either have or are at risk of thoracic insufficiency syndrome, a condition often linked to scoliosis that prevents the chest walls from supporting normal breathing and lung development.
Because removing and replacing the device can introduce “a known harm” to patients, according to the safety notice, NuVasive stopped short of outright recommending early removal for those who have had the implant for more than two years or who fall outside the new intended use group. Instead, healthcare providers are advised to review the new instructions for use, consider continued treatment options on a patient-by-patient basis and assess these patients at least every six months.
In a safety communication of its own, the FDA noted that NuVasive’s safety notice and updated labeling don’t affect devices sold in the U.S., but rather align the worldwide indications for the device with those of the FDA, which had only ever cleared the MAGEC system for periods of up to two years.
The FDA’s notice also confirms that the global ship hold of the MAGEC system has been lifted. Meanwhile, the U.S. regulator gave NuVasive the go-ahead to resume regional shipping back in July, when it determined that the benefits of the system outweighed any potential risks.
Among those risks is an issue flagged in early 2020 in which the implant’s endcap and rod can come apart, potentially exposing patients to internal components that haven’t been fully tested for biocompatibility. The issue is confined to about 0.5% of the devices, according to the company.
In February 2020, NuVasive recalled the MAGEC system to address the issue—a recall that garnered the FDA’s mid-level Class II rating—then received a new FDA clearance the following July for an updated version of the rod that was supposed to prevent the endcap from separating. Early this year, however, the FDA said it began to receive reports of tissue reactions that may be related to the endcap issue.
This ongoing issue sparked the temporary pause on the device’s CE mark and NuVasive’s global ship hold in April. Meanwhile, the company said it was working closely with the FDA to conduct biocompatibility testing of all the components of the system, prompting the agency to allow U.S. sales to resume in July, even as the testing continued.
At the time, NuVasive said it had stopped production of all versions of the MAGEC system except the updated Model X cleared by the FDA in July 2020.