Paradigm Spine: coflex Coverage Policy News

Paradigm Spine, headquartered in New York City, has announced that the North American Spine Society (NASS) has issued a coverage policy recommendation for Lumbar Interlaminar Device without Fusion and with Decompression. The company points out the particular significance for its product, coflex, a lumbar motion preservation solution.

Marc Viscogliosi, chairman and CEO of Paradigm Spine, told OTW, “NASS is the preeminent U.S. spine society and health insurance companies and providers look to it for guidance, this decision will open the door to enabling further access to more private payors in the U.S. market.”

 

Paradigm Spine Announces NASS Coverage Policy Recommendation for coflex Interlaminar Stabilization – Spinal News International

The North American Spine Society (NASS) has issued a coverage policy recommendation for Lumbar Interlaminar Device without Fusion and with Decompression, which applies to Paradigm Spine’s coflex device. This recommendation is particularly significant for coflex because it provides the evidence private health insurance companies require to allow access for patients to benefit from this technology.

The policy recommendations cover the use of spinous interlaminar devices, in conjunction with a direct decompression procedure. However, the only FDA approved, on-label device that currently matches this product class is coflex. The coflex device, as described by Paradigm Spine, is the exclusive lumbar motion preservation solution with proven long-term outcomes for durable pain relief and stability for patients with moderate to severe lumbar spinal stenosis.

NASS Coverage Policy Recommendation for Lumbar Interlaminar Device

Paradigm Spine announced that the North American Spine Society (NASS) issued a coverage policy recommendation for Lumbar Interlaminar Device without Fusion and with Decompression. This is significant for Paradigm’s coflex® Interlaminar Stabilization® device, as it provides private payors with evidence to allow access for the technology.

The NASS coverage policy recommends use of coflex to treat lumbar spinal stenosis, and only applies to devices used with a direct decompressive procedure. To date, coflex is the only device that satisfies these conditions.

Paradigm Spine Receives FDA PMA for Disposable Instrumentation Kit for Spinal Stenosis

Paradigm Spine LLC announced the FDA granted pre-market approval for the coflex interlaminar stabilization disposable instrument kit for the treatment of lumbar spinal stenosis.

According to a company press release, this is the first disposable spinal instrument kit for a class III spinal device to receive supplemental pre-market approval (PMA). The coflex is a posterior lumbar motion-preservation solution for patents with moderate to severe spinal stenosis. The kit will include injection-molded instruments in a pre-sterilized peel pack.

 

Paradigm Spine Receives FDA Pre-Market Approval (PMA) For First Of Its Kind Disposable Instrument Kit

Marks first approved disposable spinal instrument set for a Class III spinal device

NEW YORK, May 2, 2018 /PRNewswire/ — Paradigm Spine, LLC, a leader in providing motion preservation solutions for the treatment of lumbar spinal stenosis, today announced that the U.S. Food and Drug Administration (FDA) has granted pre-market supplemental approval (PMA) for its coflex® Interlaminar Stabilization® disposable instrument kit. This marks the first approved disposable spinal instrument set for a Class III spinal device to receive a supplemental PMA approval, the most stringent type of device marketing application required by FDA.

Paradigm Spine Highlights Data Presented At ISASS 2018 Further Validating Decompression with coflex

NEW YORKApril 30, 2018 /PRNewswire/ — Paradigm Spine, LLC, a leader in providing motion preservation solutions for the treatment of lumbar spinal stenosis, today announced results of three subanalyses from studies of coflex® that further validate the efficacy and benefit to patients with lumbar spinal stenosis. The data were presented during three scientific podium presentations at the 2018 International Society for the Advancement of Spine Surgery (ISASS), held April 11-13 in Toronto, Canada.