Nevro has received the CE mark for full-body magnetic resonance imaging (MRI) conditional labelling on the Senza Spinal Cord Stimulation (SCS) System delivering HF10 Therapy.
This approval (which is applicable only to European Economic Area countries) adds to the previous labelling allowing head and extremity MRI scans, broadening the pool of patients who are eligible to receive the Senza SCS System, including both model IPG1000 and IPG1500. This approval is retroactive, meaning that the new labelling for expanded imaging applies to all patients currently implanted with the Senza SCS System with percutaneous leads.
“Our R&D and regulatory teams worked hard to secure this approval for both current and future Senza patients,” says Rami Elghandour, president and CEO of Nevro. “We believe in expanding patient access to HF10 Therapy and this approval enables us to help chronic pain patients who may have additional imaging needs. We are dedicated to continually improving on the Senza System to not only deliver superior patient outcomes, but also provide the best patient experience in the SCS space.”
“HF10 Therapy is life-changing for my patients,” says Mohammad Maarouf, associate professor and head of the Department of Stereotaxy and Functional Neurosurgery at Cologne Merheim Medical Center, University of Witten/Herdecke, Germany. “I am happy that all of my patients past and future now have access to superior outcomes with the reassurance that patients with percutaneous systems can safely have a full-body MRI should the need arise.”