Premia Spine, a spinal implant company focused on commercializing innovative lumbar solutions, announced the launch of the ProMIS Fixation System with its Advanced MIS screw placement at the International Society for the Advancement of Spine Surgery Meeting in Las Vegas.
Dr. Steven DeLuca, from the Orthopedic Institute of Pennsylvania, and Dr. Joshua Ammerman, Chairman, Department of Surgery, Sibley Memorial Hospital performed the first cases at their respective hospitals with the novel pedicle screw fixation system.
The ProMIS™ Fixation System offers several advantages over other MIS systems, including a choice of screw placement techniques in one instrument kit. Surgeons can select from an innovative k-wireless technique, a direct Skin-to-Screw placement, a Tap-Shidi approach, and a traditional reusable Jamshidi technique.
"With interchangeable screw placement techniques, I can switch intraoperatively based on my assessment of the situation," comments Dr. Ammerman.
"The Direct Skin-to-Screw placement technique saves several steps and reduces x-ray exposure to my patients and me," explains Dr. DeLuca.
"I make my incision, place the screw with an extended k-wire tip at my desired entry point, radiographically confirm orientation, mallet the k-wire tip into the pedicle, and then simply advance my screw as I retract the k-wire into the cannulated screw body."
Ron Sacher, Chief Executive Officer of Premia Spine, commented, "The ProMIS System is a breakthrough in instrumentation. We have fewer instruments and fewer steps. That saves OR time and reprocessing costs."
ProMIS also offers a unique pedicle screw which is supplied in an individual sterile pack. The Premia Spine screw has a patented surface treatment that promotes bony ingrowth. The proprietary implant surface technology consists of a unique roughened topography that creates an optimal screw-bone response and promotes bone growth into the micro-crevices of the screw surface.
A peer-reviewed study published in the Journal of Bone and Joint Surgery by Professors Schwartz and Boyan demonstrated significant resistance to pullout forces with the Premia Spine pedicle screw. In the sheep study, 2.3 times the force was required to remove the screw with the surface treatment versus a non-treated screw.
Premia Spine was founded in 2011 after acquiring rights to the TOPS™ System from Impliant, Inc. Nearly $70 million was invested in the development and commercialization of the TOPS System by Impliant.
Premia Spine has leveraged the acquired know-how to redesign the TOPS device and develop the ProMIS System.