Carlsmed has revealed that the first patients have been enrolled in the COMPaSS study, a multicentre post market prospective observational registry which will collect data up to two years on patients with degenerative spinal conditions who are treated surgically with the company’s aprevo devices.
Roland Kent, the study’s chief investigator, said: “The COMPaSS study will generate first-of-its-kind preoperative intervertebral data for surgical planning and personalised aprevo designs along with postoperative metrics for spinal alignment and clinical outcomes. After observing excellent initial results with aprevo in my own patients, I am excited to collaborate with colleagues across the country to verify durability of achieved spinal alignment and assess patient satisfaction over the next two years.”
The COMPaSS study will evaluate spinal alignment, complications, and patient reported outcome measures for a wide variety of patients with degenerative spinal conditions.
Mike Cordonnier, CEO of Carlsmed, added: “The COMPaSS study further advances Carlsmed’s mission to collect data and improve outcomes of patients through the power of personalised spine surgery. The ongoing commitment to real-world data collection will continue to drive the transformation to deep personalisation of surgical devices and procedures.”