The US Food and Drug Administration (FDA) has awarded a pre-market supplemental approval (PMA) to Paradigm Spine ’s disposable instrument set for its Class III spinal device.
The coflex Interlaminar Stabilization device is understood to be the first spinal instrument to obtain FDA approval.
Paradigm Spine said that its kit is a posterior lumbar motion preservation solution and demonstrated long-term outcomes for patients suffering from moderate to severe spinal stenosis.
The simplified set will comprise injection moulded instruments in a pre-sterilised peel pack. It comes with a future option for implantation of coflex that is considered effective in the outpatient care setting.
Paradigm Spine chairman and CEO Marc Viscogliosi said: “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.
“These kits are ideal for outpatient and ambulatory surgery centres 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.”
Lumbar spinal stenosis, which affects 1.6 million people in the US each year, is a debilitating and degenerative condition characterised by leg and back pain, leg numbness and weakness.
The disease is usually treated through surgical decompression alone or in combination with lumbar fusion.