MRI Outcomes of VersaWrap Nerve Protector Following Surgery

This study is a prospective, post-market, observational multi-center evaluation of the use of VersaWrap. Patients identified by the Investigator in their practice as needing a bilateral lumbar decompression at one level (L4-S1) and meeting all the inclusion and none of the exclusion criteria. Patients will consent to participating in the study, prior to any study procedures.

Inclusion criteria

• Patients aged ≥18 and ≤65 at time of surgery
• Patients undergoing lumbar decompression bilaterally at one level from L4-S1
• Psychologically, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule, study requirements with a signed informed consent.

Exclusion criteria

• Non-English speaking
• Known allergy or sensitivity to citrate, alginate or hyaluronate
• Known allergy or sensitivity to MRI contrast dye
• Known to experience claustrophobia
• Pregnant or breastfeeding at time of surgery
• Incarcerated at time of surgery
• Prior lumbar surgery at the index level
• Conjunction device use at index level (i.e., Barricade)*
• Patient has any condition, that in the opinion of the Investigator, would prohibit the patient from complying with the protocol *Note: conjunction medications (i.e., Depo-Medrol, Marcaine/Epinephrine) are acceptable