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Paradigm Spine gets FDA pre-market approval for disposable instrument kit

MDBR Staff Writer Published 03 May 2018

Paradigm Spine has secured pre-market supplemental approval (PMA) from the US Food and Drug Administration (FDA) for its coflex Interlaminar Stabilization disposable instrument kit.

Claimed to be the first of its kind disposable spinal instrument set, the coflex Interlaminar Stabilization is the exclusive posterior lumbar motion preservation solution for patients with moderate to severe spinal stenosis.

The newly approved disposable instrument kit is provided with a future additional option for implantation of coflex, which is suitable in the outpatient setting of care.

The kit includes a complete and simplified set of injection molded instruments delivered in a pre-sterilized peel pack. 

The coflex Interlaminar Stabilization device is currently marketed in more than countries across the globe.

Paradigm Spine’s coflex is said to be the only lumbar spinal device that produced level I evidence in two separate prospective, randomized and controlled studies against two different control groups, altering the standard of care for lumbar spinal stenosis treatment.

Paradigm Spine chairman and CEO Marc Viscogliosi said: "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."

Lumbar spinal stenosis, which is affecting 1.6 million patients per annum in the US, is a debilitating and degenerative disease associated with significant leg and back pain, leg numbness and weakness.

Established in 2004, Paradigm Spine is engaged in the designing and development of solutions for the disease management of spinal stenosis.


Image: Paradigm Spine’s coflex Interlaminar Stabilization disposable instrument kit PRNewsfoto/Paradigm Spine, LLC.