- NuVasive has resumed U.S. shipments of its titanium-based Precice devices after updating its instructions for use of the products.
- Global shipments of the devices, which are used to lengthen or shorten limbs, stopped in April as NuVasive worked through the biocompatibility issues raised by European authorities. The stainless steel devices remain off the market but titanium models are available again.
- FDA on Wednesday voiced its support for the reintroduction of the titanium-based Precice devices, telling healthcare providers that making the orthopaedic products available is in the best interest of patients as the benefits outweigh the known risks.
NuVasive has faced biocompatibility concerns for a range of medical devices this year. The orthopaedic company permanently stopped U.S. sales of MAGEC 1.5 and 2 scoliosis medical devices and paused shipments of other MAGEC and Precice products. NuVasive lifted the hold on its modified "X" version of MAGEC over the summer but kept the restrictions on the Precice product line.
That changed last month when NuVasive first lifted the holds on Precice IMLL and Short and, later, Precice Unyte and Freedom. NuVasive lifted the last of the holds on Tuesday, when it also published an Urgent Field Safety Notice to disclose the actions.
The notice communicated the resumption of Precice shipments and changes to the instructions for use. The U.S. instructions for all four Precice products now limit use to patients aged 18 years and older. NuVasive has also added a warning that patients "should not be implanted with more than two devices at a time and the patient's weight should be a minimum of 50 lbs."
Some patients who do not meet the new criteria for use may already have received the implants. If a patient weighs less than 50 pounds or has more than two devices implanted, NuVasive is advising the healthcare team to assess the progression of the treatment and consider the prompt removal of nails at the end of treatment.
FDA followed up with a letter to healthcare providers. The agency reiterated NuVasive's advice to healthcare professionals, adding that "the overall benefits of the devices outweigh the known risks for on-label use with the updated labeling, compared to alternative treatments." FDA is continuing to work with NuVasive to evaluate additional biocompatibility assessments.
Getting the products back on the market could remove a drag on NuVasive's performance. Last month, NuVasive said ex-U.S. growth was largely offset by the pause on shipments and that it took a $14.2 million inventory charge in relation to product withdrawals. NuVasive expects to have titanium Precice devices back in most key markets by the end of the year.