Carlsmed has been granted breakthrough device designation from the U.S. Food and Drug Administration (FDA) for its aprevo technology to treat patients with cervical spine disease.
 
This is the company’s second breakthrough device designation, complementing its lumbar patient-specific interbody fusion devices for anterior, lateral, and transforaminal approaches.
 
“Maintenance of sagittal balance after anterior cervical discectomy and fusion procedures is an important parameter to reduce risk for subsequent degeneration at adjacent levels,” said Christopher Ames, MD, director of spinal tumor and spinal deformity surgery at UCSF Medical Center, told the press. “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.”
 
Carlsmed’s digital technology platform creates personalized fusion devices for each patient. The bespoke aprevo devices are 3D-printed, sterile packed, and delivered right to the hospital for surgery.
 
Carlsmed anticipates launching aprevo for cervical spine disease in the U.S. in 2025.
 
“Our goal is to accelerate deployment of patient-centric pioneering technology that revolutionizes the standard of care for spine surgery,” said Mike Cordonnier, CEO of Carlsmed. “Expanding the application of our personalized solutions to help patients suffering from cervical spine disease is the next natural step for our portfolio.”