Carlsmed recently announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation for Aprevo—a technology used in the treatment of patients with cervical spine disease.
This is Carlsmed’s second Breakthrough Device designation, as per a company press release, complementing its family of 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 (University of California San Francisco [UCSF] Medical Center, San Francisco, USA). “Using Aprevo personalised 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 one-of-a-kind fusion devices for each patient, the release adds. The bespoke Aprevo devices are 3D printed, sterile packed, and delivered directly to the hospital for surgery.
“Our goal is to accelerate deployment of patient-centric, pioneering technology that revolutionises the standard of care for spine surgery,” said Mike Cordonnier, CEO of Carlsmed. “Expanding the application of our personalised solutions to help patients suffering from cervical spine disease is the next natural step for our portfolio.”
Carlsmed’s Aprevo device for the treatment of cervical spine disease is anticipated to be launched in the USA in 2025, the company’s recent release notes.