Paradigm Spine said today it won FDA premarket approval for its Coflex Interlaminar stabilization disposable instrument kit, touting it as the first FDA PMA-cleared disposable spinal instrument set for a Class III spinal device.
The Coflex interlaminar stabilization system is the New York-based company’s flagship device, and is designed for posterior lumbar preservation in patients with moderate to severe spinal stenosis.
“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. Having a disposable Coflex 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,” NeoSpine prez Dr. Richard Wohns said in a prepared statement.
The newly cleared kit is designed to enable an additional future option for implantation of the Coflex in an outpatient setting, and consists of a complete and simplified set of injection molded instruments in a pre-sterilized pack, Paradigm Spine 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 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,” chair & CEO Marc Viscogliosi said in a press release.