FDA Grants Carlsmed Technology a Second Breakthrough Device Designation
Thursday, September 21, 2023
Carlsmed made an announcement today regarding the FDA's granting of Breakthrough Device designation for its aprevo® technology aimed at treating individuals with cervical spine disease. Significantly, this marks the second time Carlsmed has received such a designation, complementing its existing range of patient-specific lumbar interbody fusion devices for anterior, lateral, and transforaminal approaches.
Maintenance of sagittal balance after anterior cervical discectomy and fusion procedures is a crucial factor in reducing the risk of subsequent degeneration at adjacent levels stated Dr. Christopher Ames, who serves as the Director of Spinal Tumor and Spinal Deformity Surgery at UCSF Medical Center in California. He emphasized that the utilization of aprevo® personalized interbody devices, combined with thorough preoperative planning for cervical procedures, could provide surgeons with a more dependable approach to achieving optimal alignment tailored to each patient's unique requirements.
Carlsmed's advanced digital technology platform specializes in crafting customized fusion devices for individual patients. These unique aprevo® devices are manufactured using 3D printing, sterilized, and then delivered directly to the hospital in preparation for the surgical procedure.
Mike Cordonnier, the CEO of Carlsmed, expressed the company's mission to expedite the adoption of patient-centric innovative technology, transforming the standard of care in spine surgery. He added, "Expanding the application of our personalized solutions to assist patients suffering from cervical spine disease is a natural progression for our product portfolio.
In the United States, there are more than 350,000 cervical fusion surgeries performed annually, and this number is growing at nearly twice the rate of lumbar fusion surgeries. Carlsmed plans to launch its aprevo® device for the treatment of cervical spine disease in the U.S. in 2025.