Vertiflex has announced additional results from a randomised, controlled trial of its Superion Indirect Decompression System in patients with lumbar spinal stenosis (LSS). The results, published in the Journal of Pain Research, showed an 85% decrease in the proportion of patients who were using opioids five years after being treated with interspinous process decompression (IPD) using the Superion device. The study was conducted under an Investigational Device Exemption with the US Food and Drug Administration (FDA).
Superion received Premarket Approval (PMA) from the FDA in 2015 for the treatment of LSS. The condition causes significant pain, disability, functional impairment and diminished quality of life. It is the most common indication for spine surgery in older adults. In the USA, LSS affects more than 14 million patients.
“These findings demonstrate that treatment with IPD, a minimally-invasive treatment option for LSS, can provide effective pain relief while markedly decreasing the need for prescription opioid medications,” said Pierce D. Nunley, lead author of the publication and director of the Spine Institute of Louisiana.
The trial estimated the type, dosage and duration of opioid medications through five years of postoperative follow-up after IPD with the Superion device. Data were obtained from the Superion treatment arm of a randomised, controlled, noninferiority trial. The prevalence of patients using opiates was determined at baseline, 6 weeks, and at 3, 6, 12, 18, 24, 36, 48 and 60 months. The primary analysis included all 190 randomised patients receiving the Superion device.
At baseline, nearly 50% (94 of 190) of patients were using opioid medications. Results of 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, there was an 85% decrease in the proportion of patients using opioids.
“With growing concerns over prescription opioid overuse and misuse, which can lead to addiction, any effective strategies that can decrease or even eliminate the need for opioid therapy in patients with LSS are welcome,” said Tim Deer, an author on the publication and president and CEO, The Spine and Nerve Centre of the Virginias.