Following an FDA supplemental approval, a new disposable spinal instrument kit will be available to outpatient and ambulatory surgery centers. The approval marks the first time the agency has signed off on such a kit for a class III spinal device, according to New York-based Paradigm Spine LLC. The kit will complement Paradigm Spine's Coflex interlaminar stabilization product, which is indicated for use in one or two level lumbar stenosis in skeletally mature patients. These patients have at least moderate impairment in function and have undergone six months or more of nonoperative treatment. Implantation of the interlaminar stabilization device follows decompression of stenosis at the affected level(s). The kit will add an implementation option for Coflex – particularly in the outpatient setting – and includes a set of injection molded instruments in a presterilized peel pack.
"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," said Marc Viscogliosi, chairman and CEO of Paradigm Spine. "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 (LSS) affects about 1.6 million U.S. patients each year. It often is associated with leg and back pain, as well as numbness or weakness in the leg. Traditionally, the two surgical treatment options for LSS were decompression alone or decompression with lumbar fusion.
Paradigm Spine reported Oct. 17, 2012, that the FDA had approved Coflex. At the time, the company noted that it was the first PMA to collect health care economic data for spinal stenosis. Data and resulting analyses showed that Coflex could save the health care system an average of $5,000 to $8,700 per case versus pedicle screw fusion, the company said. Coflex now is available in more than 60 countries.
"Having a disposable Coflex surgical kit will be ideal for simplifying and streamlining our operating room activities, particularly in ambulatory surgery centers," said neurosurgeon Richard Wohns, who also is the founder and president of Neospine LLC in Puyallup, Wash. He noted that having instruments that are sterile saves labor costs and lowers the risk of potential infection.
Word of the approval came two days after the company reported results of three subanalyses from studies of Coflex. These data were presented during three scientific podium presentations at the 2018 International Society for the Advancement of Spine Surgery last month in Toronto. The company noted that using Coflex allowed for shorter operative times and hospitals stays, as well as decreased blood loss, when compared with fusion.
Additional data provided a subanalysis of a cohort from the FDA investigation device exemption trial comparing the efficacy of decompression with Coflex versus decompression with fusion. The data showed that the hospital stay associated with Coflex was almost two days shorter versus fusion.
Vertiflex Inc. offers the Superion interspinous spacer system for moderate LSS in the U.S. It reported that it had completed a $40 million series C funding round in March 2017. (See BioWorld MedTech, March 9, 2017.) Proceeds were earmarked for the commercial expansion of Superion. The company scored approval for its offering in May 2015.
During an FDA advisory committee meeting on Superion, panelists voted four to two, with two abstentions, on the benefit/risk question. (See BioWorld MedTech, Feb. 24, 2015.) Panelists criticized the study design, as they appeared to prefer head-to-head trials that demonstrate superiority to existing technology.
An FDA panel dealt Memphis, Tenn.-based Medtronic Sofamor Danek, a business of Medtronic plc, a blow in February 2016 regarding the Diam spinal stabilization system. (See BioWorld MedTech, Feb. 24, 2016). Ahead of the meeting, the FDA said in briefing information that the Diam pivotal study had been conducted in such a manner as to introduce the risk of bias. (See BioWorld MedTech, Feb. 22, 2016.) Ultimately, there were four votes in favor of the device's risk-benefit profile, while seven members went against the company on this question.