NuVasive resumes US sales of Precice devices following positive biocompatibility tests

USA – NuVasive has resumed U.S. shipments of its titanium-based Precice devices after receiving a greenlight from the FDA based on positive biocompatibility testing  results.

Global shipments of the devices, which are used to lengthen or shorten limbs, ceased in April while NuVasive addressed biocompatibility concerns raised by European authorities. The stainless-steel devices are still unavailable, but titanium models are back on the market.

NuVasive, a medical device company focused on developing devices and procedures for minimally invasive spine surgery, has resumed U.S. shipments of titanium-based version of its MAGEC Precice devices after positive biocompatibility from biocompatibility testing updating its instructions for use of the products.

The previous version of the MAGEC spinal implant was flagged for potential mechanical risks by the US Food and Drug Administration (FDA). NuVasive is continuing to collaborate with the health agency to address the device’s safety concerns.

The instructions for all four Precice products in the United States now restrict use to patients aged 18 and up.

NuVasive has also added a disclaimer that patients “should not be implanted with more than two devices at the same time, and the patient’s weight should be at least 22.67 kgs (50 pounds).”

The company also cautioned against removing existing implants before the recommended date. The MAGEC implant system is approved for use for two years in the United States and up to six years in the European Union.

Some patients who do not meet the new use criteria may have already received the implants. If a patient weighs less than 50 pounds or has more than two devices implanted, NuVasive advises the healthcare team to assess treatment progression and consider prompt nail removal at the end of treatment.

The stainless-steel devices are still unavailable, but titanium models are back on the market. NuVasive is currently testing these parts’ biocompatibility to ensure that they will not cause any adverse local reactions if they come into contact with living tissue.

Product recall

NuVasive’s spinal implant has long been plagued by problems. The problems began early last year, when the company recalled the MAGEC systems due to endcap separation reports.

NuVasive issued the recall notice in February 2020, stating that the problem occurred in approximately 0.5 percent of the implanted devices and that the cause is being investigated.

Following its investigations, the FDA assigned the recall a mid-level Class II label, implying the possibility of temporary or fully treatable reactions to the device and only a remote risk of severe reactions.

A few months later, in July 2020, the FDA approved an updated version of the MAGEC Model X rod spinal implant designed to reduce the risk of endcap separation.

The problems resurfaced in early 2021, when the FDA began to receive reports of local tissue reactions that could have been caused by the endcap separation issue.

In response to the concerns, NuVasive halted global shipments of all versions of the spinal rod device in April.

It also stated that all versions of MAGEC would be discontinued, with the exception of the most recent updated edition (Model X).

The NuVasive spinal implants are indicated for patients under the age of ten who have developed, or are at risk of developing, thoracic insufficiency syndrome, a condition that frequently arises as a result of scoliosis in which the chest wall fails to support normal breathing or lung development.

While the device is still being tested, the FDA has advised providers and caregivers to keep an eye out for any unexpected back pain, inflammation, or deformities in patients who have received MAGEC and to report any adverse events to the agency as soon as possible.

Unfortunately for NuVasive, this isn’t its only device to be concerned about. On July 8, the FDA issued a safety notice to healthcare providers regarding biocompatibility concerns with the company’s Specialized Orthopedics Precice devices made of stainless steel and titanium.

The FDA has also issued its own notice. Different recommendations were made by the agency for stainless steel and titanium devices.

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