Vertiflex has announced publication of data analysis demonstrating 85% reduction in patients using opioids following treatment With Superion Indirect Decompression System.
The company announced additional results from a randomized, controlled trial of its Superion Indirect Decompression System in patients with lumbar spinal stenosis (LSS).
The study was conducted under an investigational device exemption with the US Food and Drug Administration (FDA).
Superion secured premarket approval from the FDA in 2015 for treating LSS, a common degenerative condition where the spinal cord narrows, compressing nerves that travel through the lower back into the legs.
LSS causes significant pain, disability, functional impairment and lowered quality of life. It is the most common indication for spine surgery in older adults. In the US, LSS is considered to affect more than 14 million patients.
The company stated that the trial included 190 patients and it calculated the type, dosage and duration of opioid medications through five years of post-operative follow-up after IPD with the Superion device. Data was obtained from the Superion treatment arm of a randomized, controlled, noninferiority trial.
Patients using opiates were determined at baseline, 6 weeks and at 3, 6, 12, 18, 24, 36, 48 and 60 months. The primary analysis included all the randomized patients receiving the Superion device.
At baseline, about 50% (94 of 190) of patients were using opioid medications. Results from the data analysis showed a marked year-over-year decrease in the proportion of patients taking opioid medication to manage LSS symptoms after Superion implantation. After five years, an 85% decrease in the proportion of patients using opioids was observed.
Vertiflex president and CEO Earl Fender said: “We are pleased by these published results demonstrating that use of the Superion device provides effective relief from back and leg pain in patients with LSS without the need for continuing opioid therapy. These results extend previous research showing that Superion results in long-term sustained clinical improvement in patients with LSS.
“Finding non-opioid approaches to treating pain is critical, and we are pleased to share these published findings and discuss their implications with the clinical community.”