The US Food and Drug Administration has approved the next-generation Senza II Spinal Cord Stimulation (SCS) System (Nevro) delivering HF10 therapy.
According to the company, the Senza II system offers the superior outcomes and clinical advantages of HF10 therapy through a smaller and more refined footprint while maintaining the performance and durability of the current Implantable Pulse Generator (IPG).
“My colleagues and I are excited about the approval of the Senza II SCS system,” says Tom Simopoulos, director of Pain Medicine and Co-Director of the Spine Center at the Beth Israel Deaconess Medical Center (an affiliate of the Harvard Medical School) in Boston, USA. “The reduced size and optimised design of the Senza II IPG allow for greater patient comfort and placement options. Most importantly, it delivers HF10 therapy, a non-opioid treatment option that provides profound and paraesthesia-free pain relief for patients.”
“We are pleased to have received FDA approval for Senza II so quickly after our recent CE mark clearance. Senza II is a step forward that represents our company’s commitment to continuously advancing our product portfolio,” says Rami Elghandour, president and CEO of Nevro. “The smaller, refined footprint delivers the unparalleled performance of our current Senza system and is backed by the same best-in-class clinical evidence that you have come to expect from Nevro and HF10. The initial product feedback from our European customers has been excellent, and we look forward to launching Senza II in the USA.”