Nevro has announced that the first commercial case has been performed in the United States under the company’s 8 May, 2015 FDA approval for commercial use of the Senza spinal cord stimulation (SCS) system, which delivers Nevro’s proprietary HF10 therapy.
“This is an exciting day for chronic pain patients and the physicians who treat them in the USA as they now have access to a significant advance in chronic pain management. HF10 therapy will broaden my pain practice as its superior results will allow me to treat more patients effectively. Additionally, the elimination of paraesthesia is meaningful for patient quality of life as well as predictability of the operating procedure. I am excited to bring these advances to my patients,” said Leonardo Kapural, lead investigator for the SENZA-RCT pivotal study from Wake Forest University Baptist Medical Center, USA.
The Senza system delivering HF10 therapy has experienced strong adoption in Europe and Australia over the past five years. With this FDA approval, patients in the USA suffering from chronic pain will have the opportunity to experience the superior benefits of HF10 therapy. Nevro’s Senza system is the only SCS therapy approved by FDA with superiority labelling, as demonstrated in the largest prospective randomised SCS study ever conducted to assess the treatment of chronic back and leg pain. The Senza system is also the only SCS therapy indicated by FDA to deliver pain relief without paraesthesia (a stimulation-induced sensation, such as tingling, burning, or pricking, which is the basis of traditional SCS), and to be approved by FDA to be used without patient restrictions on motor vehicle operation while receiving therapy. Finally, the Senza system is the only implantable SCS system approved by FDA with labelling for 3T conditional MRI compatibility.
“We are pleased we are able to initiate the commercialisation of HF10 therapy so quickly after FDA approval and to broaden access to US patients in need of an effective chronic pain treatment,” said Michael DeMane, chairman and chief executive officer of Nevro. “The Nevro team looks forward to launching the Senza system in the USA with a deliberate and responsible commercial rollout.”