November 20, 2018
CARLSBAD, Calif.–(BUSINESS WIRE)–Vertiflex® Inc., a leading innovator of advanced, minimally invasive interventions for spinal stenosis, announced additional results from a randomized, controlled trial of its Superion® Indirect Decompression System in patients with lumbar spinal stenosis (LSS). The results, published in the Journal of Pain Research (https://www.dovepress.com/articles.php?article_id=42435), showed an 85 percent 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 U.S. Food and Drug Administration (FDA).
Superion received Premarket Approval (PMA) from the FDA in 2015 for the treatment of 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 diminished quality of life. It is the most common indication for spine surgery in older adults. In the United States, 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, M.D., lead author of the publication and Director of the Spine Institute of Louisiana.
Study Design and Results
The trial estimated the type, dosage and duration of opioid medications through five years of post-operative follow-up after IPD with the Superion device. Data were obtained from the Superion treatment arm of a randomized, 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 randomized patients receiving the Superion device.
At baseline, nearly 50 percent (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 percent decrease in the proportion of patients using opioids.
“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,” said Earl Fender, President and CEO of Vertiflex. “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.”
“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, M.D., an author on the publication and President and CEO, The Spine and Nerve Center of the Virginias.
In the United States, the opioid epidemic was responsible for more than 42,000 deaths in 2016, or 116 people a day.1 About 40 percent of all opioid overdose deaths involve a prescription opioid.2
Superion is an indirect decompression device for the treatment of moderate LSS. Superion prevents compression of the nerves and vasculature in the spine while walking and standing, when symptoms most commonly manifest, and does not require the removal of any bone or tissue to implant. Superion received approval from the FDA through a Premarket Approval process based on the largest, most extensive body of device clinical evidence related to LSS.
About Vertiflex®, Inc.
Vertiflex is a privately held medical device company dedicated to the advancement of minimally invasive solutions for the treatment of lumbar spinal stenosis, which is the leading cause of spinal surgery in the elderly. Founded in 2005 and headquartered in Carlsbad, California, Vertiflex has developed a proprietary, minimally invasive technology for performing indirect decompressions of the lumbar spine. The procedure fills a gap in the stenosis treatment continuum. To date, Vertiflex has compiled the largest, most rigorous body of device clinical evidence related to lumbar spinal stenosis. For more information, visit www.vertiflex.com.
Kathryn Larson, Sr. Director, Strategic Marketing