
This prospective, multicenter, global, postmarket study aimed to evaluate the clinical performance and safety of the new InterStim PNE lead with the foramen needle. One hundred and ten subjects met the inclusion and exclusion criteria and underwent a lead implant procedure. In addition, 108 had a successful procedure, and 107 completed the 1‐week follow‐up visit. The updated InterStim PNE lead with a more robust design and greater distensibility designed to reduce migration was shown to have a high motor or sensory response rate during lead placement. Furthermore, subjects reported high rates of global improvements and amelioration of symptoms, and the lead was easy to remove with minimal morbidity.
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