Disposable Kit Pre-Market Approved for Lumbar Spinal Stenosis Device

The US Food and Drug Administration (FDA) has given pre-market supplemental approval (PMA) to a disposable spinal instrument set for a Class 3 spinal device — the first time such a kit has been given that indication.

The coflex Interlaminar Stabilization disposable instrument kit, from Paradigm Spine, is a serviceable outpatient set of injection molded instruments provided in a pre-sterilized peel pack for Paradigm’s signature posterior lumbar motion preservation solution. The coflex Interlaminar Stabilization solution is designated for the long-term treatment of patients with moderate to severe lumbar spinal stenosis (LSS).

LSS currently affects about 1.6 million US patients annually, with degenerative characteristics that result in symptoms of leg and back pain, leg numbness and weakness, and a significant reduction in active lifestyle. According to Paradigm Spine, the 2 traditional surgical treatment options for LSS have included lone decompression or combination decompression and lumbar fusion. Though both provide pain relief to patients, subsequent invasive therapy may still be necessary.

Richard N.W. Wohns, MD, neurosurgeon, founder and president, NeoSpine in Puyallup, WA, expressed excitement for the supplemental resources approved for the solution procedure.

“Having a disposable coflex surgical kit will be ideal for simplifying and streamlining our operating room activities, particularly in ambulatory surgery centers,” Wohns said. “It's a great value proposition to have reliable availability of instruments that are guaranteed sterile, saving labor costs in preparation time, increasing efficiency in the operating room, and diminishing potential infection risk vs. traditional reusable instruments."

Marc Viscogliosi, Chairman and CEO, Paradigm Spine, said in a statement that the first PMA-approved Class 3 spinal device disposable instrument kit will only improve patient and physiciain experience with coflex.

“These kits are ideal for outpatient and ambulatory surgery centers because they are simple, disposable, sterile, and will reduce both financial and operational burdens on facilities,” Viscogliosi said. “In addition, through a more streamlined manufacturing process, the kits are created to have a low carbon footprint, so they benefit physicians without causing excessive harm to the environment."

The coflex Interlaminar Stabilization device is currently used in more than 60 countries, serving as the only lumbar spinal device to have produced Level 1 evidence in 2 separate randomized, controlled studies against 2 different control groups for the treatment of patients with LSS.