FDA approves spinal cord stimulation device for chronic pain

A new spinal cord stimulation device—the Senza II Spinal Cord Stimulation (SCS) System—has been approved by the US Food and Drug Administration for the treatment of chronic pain.

The Senza II delivers HF10 therapy, which is an SCS treatment comprised of electrical pulses delivered to the spinal cord to alleviate pain. Small electrodes are placed near the spinal cord to deliver the electrical pulses at 10 kHz. The electrodes are connected to a compact generator powered by batteries that is implanted under the skin.

"My colleagues and I are excited about the approval of the Senza II SCS system," said Tom Simopoulos, director, Pain Medicine and co-director, Spine Center, Beth Israel Deaconess Medical Center, Boston, MA. "The reduced size and optimized design of the Senza II IPG allow for greater patient comfort and placement options. Most importantly, it delivers HF10 therapy, a nonopioid treatment option that provides profound and paresthesia-free pain relief for patients."

Currently, HF10 therapy is the only SCS treatment that has been shown to provide pain relief without paresthesia, and is the first therapy shown to be superior to traditional SCS for back and leg pain. Leonardo Kapural, MD, PhD, pain specialist, Carolinas Pain Institute and Center for Clinical Research, and professor of anesthesiology, Wake Forest University School of Medicine, Winston Salem, NC, and colleagues published results of a randomized, parallel-arm, noninferiority study in Pain. The results showed that SCS delivered at 10kHz offered pain relief without causing the paresthesia typically due to traditional low-frequency SCS.

Of 171 subjects with both back and leg pain, 84.5% of those implanted with HF10 experienced relief of back pain and 83.1% of leg pain, compared with 43.8% and 55.5%, respectively, of those treated with traditional SCS (P < 0.001 for both). Over 12 months, HF10 therapy maintained superiority over traditional SCS for these indications (P < 0.001). Importantly, patients treated with HF10 therapy did not experience paresthesia.

“HF10 therapy promises to substantially impact the management of back and leg pain with broad applicability to patients, physicians, and payers,” concluded Dr. Kapural and fellow researchers.