FDA Approves Spinal Cord Stimulation Device for Chronic Pain

The US Food and Drug Administration (FDA) has approved the Senza II Spinal Cord Stimulation (SCS) System, a non-opioid chronic pain therapy device that delivers electrical pulses to the spinal cord.

The Senza II, from medical device company Nevro Corporation, delivers the company’s proprietary HF10 electrical pulse therapy to the spinal cord through small electrodes on leads that are placed near the treatment area. The therapy is generated by a batter-powered device implanted under the patient’s skin.

The HF10 therapy is the only SCS therapy indicated by the FDA to provide pain relief without paresthesia, according to Nevro. It was the first SCS therapy to demonstrate superiority to common SCS therapies for back and leg pain in a comparative pivotal study.

The updated Senza 2 system is designed to provide improved clinical outcomes of SCS therapy, with a smaller environmental footprint than its predecessor, according to Nevro.

Rami Elghandour, President and Chief Executive Officer of Nevro, called the most recent device approval a “step forward” in the company’s commitment to advance its product portfolio.

“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've come to expect from Nevro and HF10,” Elghandour said. “The initial product feedback from our European customers has been excellent, and we look forward to launching Senza II in the United States."

Tom Simopoulos, MD, Director of Pain Medicine and Co-Director of the Spine Center at the Beth Israel Deaconess Medical Center in Boston, MA, expressed excitement for the Senza II SCS System approval.

“The reduced size and optimized design of the Senza II IPG allow for greater patient comfort and placement options,” Simopoulos said. “Most importantly, it delivers HF10 therapy, a non-opioid treatment option that provides profound and paresthesia-free pain relief for patients.”

The FDA approval of Senza II SCS System comes during another development in the field of SCS therapy, as Medtronic announced patient enrollment in its Vectors Post Market Clinical Study on Tuesday.

The study, which will analyze the treatment of patients with chronic intractable pain with the Evolve^SM workflow SCS device, is looking to enroll up to 175 patients with chronic intractable pain of the lower back and legs. Researchers will assess the long-term efficacy of SCS, as well as its impact on quality of life, in a 12-month post-implant evaluation.

Evolve is the world's smallest implantable SCS neurostimulator. The goal of the treatment is to improve or restore function in patients, Michael Fishman, MD, from The Center for Interventional Pain & Spine in Wilmington, DE, said.

"Even with all of today's technological advances, chronic pain can be challenging to manage; this is further complicated by the opioid crisis," Fishman said. "Standard treatment guidance has the potential to help optimize pain relief, and the Vectors Post Market study will provide valuable data about the efficacy of high dose stimulation using standardized programming through the Evolve workflow."