The FDA has granted its first Pre-Market Supplemental Approval (PMA) for a disposable spinal instrument set.
That’s the news on May 2, 2018 out of Paradigm Spine, LLC, about the company’s coflex Interlaminar Stabilization disposable instrument kit.
coflex Interlaminar Stabilization is Paradigm’s signature product and the “exclusive posterior lumbar motion preservation solution with proven long-term outcomes for patients with moderate to severe spinal stenosis,” according to the company.
The kit will consist of a “complete and simplified” set of injection molded instruments delivered in a pre-sterilized peel pack. The kit is targeted to the outpatient setting.
Neurosurgeon Richard N.W. Wohns, M.D., JD, MBA, founder and president of NeoSpine, LLC in Puyallup, Washington, said having a disposable surgical kit “will be ideal for simplifying and streamlining our operating room activities, particularly in ambulatory surgery centers. 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 of Paradigm Spine said the 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. 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.”
coflex Indications
According to the FDA’s original approval of the coflex in 2012, the device “is indicated for use in one-or two-level lumbar stenosis from L1- L5 in skeletally mature patients with at least moderate impairment in function, who experience relief in flexion for their symptoms of leg/buttocks/groin pain, with or without back pain, and who have undergone at least 6 months of non-operative treatment.”
The coflex “is intended to be implanted midline between adjacent lamina of 1 or 2 contiguous lumbar motion segments. Interlaminar stabilization is performed after decompression of stenosis at the affected level(s).”
Paradigm Spine
Privately held Paradigm Spine was founded in 2004 to design and develop solutions for the disease management of spinal stenosis. The coflex Interlaminar Stabilization device, according to the company, is currently used in over 60 countries worldwide and is the only lumbar spinal device that has produced Level I evidence in two separate prospective, randomized, controlled studies against two different control groups.
