The concept for the LimiFlex™ Paraspinous Tension Band was first developed by company co-founders Louie Fielding and Todd Alamin, MD in the Stanford University Biodesign Innovation program. LimiFlex is designed to provide stabilization while preserving motion, in patients with degenerative lumbar spinal disorders for which the current standard surgical option is spinal fusion.
After receiving the CE mark in 2009, the LimiFlex™ Paraspinous Tension Band was used to treat more than 2,000 patients, primarily in Europe. The US pivotal trial is being conducted to study use of LimiFlex™ for the targeted indication of degenerative spondylolisthesis. The trial is currently fully enrolled, and the company expects to file its PMA application in 2021.
CAUTION–INVESTIGATIONAL DEVICE. LIMITED BY UNITED STATES LAW TO INVESTIGATIONAL USE.
Company’s Keywords:
<7
<20009000
<2015
Your request has been submitted successfully.
Own or work here?