The US Food and Drug Administration (FDA) has granted pre-market supplemental approval (PMA) for the coflex interlaminar stabilisation disposable instrument kit (Paradigm Spine). This marks the first approved disposable instrument set for a Class III spinal device to receive a supplemental PMA approval, the most stringent type of device marketing application required by the FDA.
Coflex interlaminar stabilisation is the leading product for Paradigm Spine, and the exclusive posterior lumbar motion preservation solution with proven long-term outcomes for patients with moderate to severe spinal stenosis. The newly approved coflex disposable instrument kit offers a future additional option for implantation of coflex that is ideal in the outpatient setting of care, a press release informs.
The disposable instrument kit will consist of a complete and simplified set of injection-molded instruments delivered in a pre-sterilised peel pack. Furthermore, the kit does not require any additional sterilisation or any preparation time prior to use; as such, it has a low carbon footprint, minimising any negative environmental impact.
“As a frequent user of coflex and experienced developer of several spinal disposable instrument sets, I am excited to have an additional resource approved for these procedures,” says neurosurgeon Richard N W Wohns (founder and president of NeoSpine, Puyallup, Washington). “Having a disposable coflex surgical kit will be ideal for simplifying and streamlining our operating room activities, particularly in ambulatory surgery centers. It is a great value proposition to have reliable availability of instruments that are guaranteed sterile, saving labour costs in preparation time, increasing efficiency in the operating room, and diminishing potential infection risk versus traditional reusable instruments.”
“We are thrilled to have the first PMA-approved disposable instrument kit for a Class III spinal device, and be able to offer this resource to our surgeon customers, further improving their experience with coflex,” says chair and CEO of Paradigm Spine Marc Viscogliosi. “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. 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. We think the streamlining and efficiency, which is everything in our patient’s surgery, really helps to facilitate a consistently reproducible experience for the surgeon.”
Paradigm Spine is currently in a limited release of the single-use sets. Further refinements to the coflex disposable instrument kit will follow based on initial feedback before full market release.