Patient-specific spine implant earns another breakthrough device designation

Spinal Tech

Carlsmed received its second FDA breakthrough device designation for Aprevo, the medtech company said Sept. 20.

The designation is for patients with cervical spine disease, according to a news release. Aprevo devices are designed specific to each patient and is designed for spinal fusions.

"Maintenance of sagittal balance after anterior cervical discectomy and fusion procedures is an important parameter to reduce risk for subsequent degeneration at adjacent levels," spine surgeon Christopher Ames, MD, said in the release. "Using Aprevo personalized interbody devices in conjunction with careful preoperative planning for cervical procedures may help surgeons more reliably achieve the optimal alignment for each individual patient."

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