Devicemaker Empirical Spine initiated the premarket approval process for use of the LimiFlex paraspinous tension band with a decompression for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis.
The clinical trial supporting the PMA compares outcomes of patients who receive either LimiFlex or transforaminal lumbar interbody fusion after decompression surgery.
"LimiFlex is an exciting new possibility for patients currently undergoing fusion for degenerative spondylolisthesis and would offer much faster recovery for patients, significant savings for payers, and more surgical offerings for spine surgeons," William Welch, MD, co-principal investigator of the trial, said in a Feb. 26 news release.
"LimiFlex also represents a new alternative as an outpatient procedure, with 2/3 of LimiFlex patients discharged the same day and almost half treated in ASC settings," Rick Sasso, MD, co-principal investigator, added.
The device is designed to stabilize the spine as an alternative to spinal fusion and is implanted after a decompression surgery. It has been implanted in more than 2,000 patients in Europe since it received the CE mark in 2009.
Click here for more details on the clinical trial.