Vertiflex yesterday released results from a trial of its Superion indirect decompression system in patients with lumbar spinal stenosis, touting a significant reduction in the number of patients using opioids to manage pain at five years post-treatment.
Results from the trial were published in the Journal of Pain Research, the company said.
“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,” lead author Dr. Pierce Nunley of the Spine Institute of Louisiana said in a prepared statement.
The Carlsbad, Calif.-based company said that the Superion indirect decompression system won FDA premarket approval for treating lumbar spinal stenosis.
“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,” study author Dr. Tim Deer of the Spine and Nerve Center of the Virginias said in a press release.
In the 190-patient trial, investigators analyzed the type, dosage and duration of opioid medications through five years of post-operative follow-ups after receiving an interspinous process decompression treatment with the Superion device.
Vertiflex said that initially, nearly 50% of patients were using opioid medications, and that after five years that number had decreased by 85%.
“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,” prez & CEO Earl Fender said in a prepared release.
In March, Vertiflex said that it raised a total of $45.3 million in a round of equity financing.