Dr. Miguel Attias and the Tampa Pain Relief Center is excited to announce that it is the first medical practice in the region to commercially implant an innovative new FDA-approved therapy for back and leg pain. The Senza SCS system, which delivers Nevro's proprietary HF10 therapy (Nevro Corporation, Menlo Park, CA), is a recently FDA-approved spinal cord stimulator that has demonstrated superior results compared to traditional SCS for the treatment of back and leg pain.
"It is very exciting to have new advanced therapeutic technology added to our arsenal to treat chronic pain conditions. It is a privilege to be the first one to utilize the Nevro Senza Spinal Cord Stimulator System in my area to help patients with severe intractable low back pain and lower extremity pain. Large, well designed and well implemented randomized clinical trials in Europe and in the United States have demonstrated superiority in relieving painful symptoms in the back and legs in the studied population. I'm confident we will able to provide similar outcomes as we incorporate HF10 therapy into our practice. The device has the added advantages of a paresthesia-free therapy, which means the patient does not require to feel the traditional buzzing sensations in the areas of pain to experience relief."
- Dr. Miguel D. Attias, Interventional Pain Specialist at Tampa Pain Relief Center- Palm Harbor
Pain is the most common reason for physician visits in the
United States. Chronic pain can significantly interfere with a person's quality of life and functionality. There are a variety of treatment options for chronic pain that range from medications to surgical interventions.
Spinal cord stimulation (SCS) offers a treatment option for chronic pain. It is most commonly used to treat severe low back and lower extremity pain. SCS uses electrical pulses to alter pain signals before they reach the brain. Hundreds of thousands of people with chronic pain have received relief with spinal cord stimulation.
In May 2015 Nevros Senza SCS system, which is the only SCS system that delivers HF10 therapy, was approved by the FDA. The FDA approval for HF10 therapy included superiority labeling over traditional SCS therapy. Specifically, HF10 therapy was found to offer superior response rates and pain relief vs. traditional SCS therapy in patients with back and leg pain. HF10 therapy is the only SCS therapy approved by FDA with a superiority labeling.
Additionally, HF10 therapy is indicated to be a paresthesia-free therapy, also a novel and unique distinction in the SCS space. Paresthesia is a stimulation-induced sensation, such as tingling, burning, or pricking, and it is the basis of traditional SCS therapy. Because it is paresthesia-free, HF10 therapy is the only SCS therapy approved by the FDA to be used without patient restrictions on motor vehicle operation while receiving therapy.
The basis for the FDA approval and the superiority labeling was the SENZA-RCT pivotal trial3, a ground-breaking clinical study that was the first to directly compare two competing SCS therapies. In the SENZA-RCT, HF10 therapy demonstrated meaningfully superior results to traditional SCS therapy for back and leg pain. In the SENZA-RCT, patients receiving HF10 therapy had a 1.5x greater likelihood of responding to the therapy over traditional SCS therapy. In addition, HF10 therapy patients achieved approximately a 50% greater improvement in pain score than those with traditional SCS therapy.
For more information, visit http://tampapainrelief.com.