Sam Brusco, Associate Editor06.28.23
Aurora Spine has enrolled the first patient in its multicenter study of the DEXA-C cervical interbody system.
This indicates the company has received all necessary approvals to launch the study, which will initially include data from 40 single level and 40 multiple level subjects.
Trent Northcutt, Aurora’s president, CEO, and co-founder, told the press, "The launch of the study is exciting news for Aurora and its DEXA platform technology. With this multicenter study now underway, we will be able to collect and provide important data to the medical industry about the DEXA-C device and technology platform.”
Principal investigator Dr. Sebastian Koga, neurosurgeon at Forrest Health Institute of Neuroscience, added, “The study will document the impact of this new biomaterial on patient outcomes in the most rigorous way. Using a prospective multi-site model will allow us to draw objective conclusions, with a focus on building confidence in adoption of the DEXA-C device by a wide range of clinicians.”
DEXA-C is used for anterior cervical interbody surgeries and is the first in a series of implants based on Aurora’s DEXA platform. Based on a DEXA T-score for measuring bone density, the platform includes implants of varying densities to match bone density. DEXA-C earned FDA clearance in 2021.
DEXA-C is meant for patient needing anterior cervical discectomy and fusion surgery. DEXA-C implants an interbody spacer(s) into cervical intervertebral body spaces to stabilize and fuse the level(s). Allograft is used in the spacer and spinal segments are fixed with an anterior cervical plate.
This indicates the company has received all necessary approvals to launch the study, which will initially include data from 40 single level and 40 multiple level subjects.
Trent Northcutt, Aurora’s president, CEO, and co-founder, told the press, "The launch of the study is exciting news for Aurora and its DEXA platform technology. With this multicenter study now underway, we will be able to collect and provide important data to the medical industry about the DEXA-C device and technology platform.”
Principal investigator Dr. Sebastian Koga, neurosurgeon at Forrest Health Institute of Neuroscience, added, “The study will document the impact of this new biomaterial on patient outcomes in the most rigorous way. Using a prospective multi-site model will allow us to draw objective conclusions, with a focus on building confidence in adoption of the DEXA-C device by a wide range of clinicians.”
DEXA-C is used for anterior cervical interbody surgeries and is the first in a series of implants based on Aurora’s DEXA platform. Based on a DEXA T-score for measuring bone density, the platform includes implants of varying densities to match bone density. DEXA-C earned FDA clearance in 2021.
DEXA-C is meant for patient needing anterior cervical discectomy and fusion surgery. DEXA-C implants an interbody spacer(s) into cervical intervertebral body spaces to stabilize and fuse the level(s). Allograft is used in the spacer and spinal segments are fixed with an anterior cervical plate.