Spinal Cord Stimulators – (HF10 Therapy)
Spinal Cord Stimulators can treat chronic pain in your back, neck, or legs, due to:
- Chronic Lower Back Pain
- Sciatic Nerve Pain
These conditions can be debilitating and for many people suffering with chronic pain, finding a long lasting solution can be difficult. At Ramos Center, we strive to offer our patients permanent solutions to alleviate pain so they can return to their daily routines.
Spinal Cord Stimulators (SCS) have become more effective than ever and it is a viable option for people suffering with chronic pain. It is a neuromodulation device that is implanted in the back. Spinal cord stimulators work by blocking pain signals being sent from your nerves to your brain. The procedure is fast and long lasting if the treatment is successful. The procedure for a spinal cord stimulator is quick and in most cases, it only requires general anesthesia which means you will be back on your feet in a matter of hours!
What is a spinal cord stimulator and how does it work?
· The category of spinal cord stimulation has been around for 35 years, however, HF10 represents a major advance in patient outcomes.
· HF10 is a small implantable medical device that sends mild electrical pulses to the spinal cord to alter pain signals traveling to the brain, thus reducing pain.
· HF10 does not require drugs or major surgery, rather just a minimally invasive procedure.
· HF10 is a safe and established therapy that been used to treat over 31,000 patients globally.
· You can try HF10 in a temporary trial to see if it is right for you.
· HF10 is major advance from traditional spinal cord stimulation devices because it works for more patients, and it provides better relief for both back and leg pain.
· The reason HF10 is so effective is that it uses very mild imperceptible pulses at a high frequency to quiet the pain-causing nerves. This is very different from the older stimulators that work by creating tingling in the patient’s pain area to distract the patient from their pain. With HF10 there is no tingling.
· HF10 is FDA-approved for use while driving, which is another big advance vs. other stimulators.
· HF10 is covered by Medicare and nearly all private insurers.
Proven Success with the HF-10
· The Senza® system delivering HF10 was FDA approved in May 2015, which came with superiority labeling from the FDA over traditional SCS therapy, as well as the paresthesia-free indication.7 The approval was supported by clinically superior outcomes in the SENZA-RCT, the largest pivotal SCS randomized controlled trial (RCT) ever conducted.
· HF10 demonstrated superiority to traditional SCS therapy at all primary and secondary endpoints, resulting in better relief for back pain, better relief for leg pain and a more significant improvement in functionality. 12 month results were published in Anesthesiology and 24 month results were published in Neurosurgery, both of which demonstrated superiority to traditional SCS8.
· The SENZA-EU study showed remarkable reductions in both back pain scores and opioid intake. The number of patients not on opioids tripled from 14 to 42 percent at two years, and the average dose per patient was reduced by nearly 70 percent9 (84 mg to 27 mg).
· In the SENZA-NSRBP pilot study, results have demonstrated that patients with non-surgical refractory back pain who received HF10 experienced significant pain reduction at 36 months of follow-up. Additionally, 90% of patients were taking opioids at baseline, which reduced to only 12% of patients at 36 months10.
Here is a list of benefits associated with the spinal cord stimulator therapy HF10:
- Proven to give patients relief from chronic back, neck, and leg pain- as many as 85% of patients reported pain relief after the procedure.
- No tingling, buzzing or shocks- a common side effect of SCS treatment is paresthesia. This side effect is categorized with tingling, shocks, or buzzing with sudden movement during daily activities. At Ramos Center, we only use the newest and most advanced technology that has been proven to eliminate chronic pain while also keeping paresthesia at bay.
- More freedom- unlike other therapies, patients can sleep and drive while the battery is on.
- Compatible with pain medications- If necessary, HF10 can be used while taking pain medication.
SENZA-RCT: A first-of-its-kind study
Leads positioned consistently for all lower back and leg pain patients
No need to wake patient
PROVEN TO GIVE MORE PATIENTS MORE RELIEF FROM BOTH BACK PAIN AND LEG PAIN
Nearly twice as many patients achieved dramatic relief from back pain and leg pain with HF10 therapy.
NO TINGLING, BUZZING, OR SHOCKS
A common side effect of most spinal cord stimulation (SCS) therapies is a tingling or buzzing sensation, known as paresthesia. For many patients, this tingling masks their pain, but it is always present.
HF10 therapy uses a unique stimulation that effectively manages chronic pain without paresthesia. Unlike traditional SCS systems, HF10 therapy won’t give you an unexpected shock when you bend, twist, or engage in other daily activities.
Unlike other SCS systems, HF10 therapy can stay ON while you are driving or sleeping.
SIMPLE, MORE PREDICTABLE, REVERSIBLE PROCEDURE
During traditional SCS procedures, patients must be awakened to help their physicians locate the most beneficial position for the electrodes.
HF10 therapy does not require patients to be awakened from a sedated state during the procedure. The implant procedure for both the trial and the permanent device is fairly quick and minimally invasive, so it may not require a hospital stay. HF10 therapy can be switched OFF and ON with the remote control at any time. If necessary, the system can be removed by your doctor.
COMPATIBLE WITH YOUR CURRENT PAIN MEDICATIONS
HF10 therapy can be used in conjunction with current medications, if necessary.
ASK YOUR DOCTOR ABOUT A TEMPORARY TRIAL OF HF10 THERAPY
HF10 therapy provides the opportunity to trial the system prior to receiving a permanent implant. The trial system delivers the same therapy provided by the implanted device, allowing you and your doctor to quickly assess its effectiveness in managing your pain.
Additional Service Areas: Manatee, Hardee, DeSoto, Charlotte, Arcadia, Venice, Ellenton, Palmetto, Parish, Lakewood Ranch, Myakka, Nokomis, Osprey, Anna Maria Island, Bradenton Beach, Longboat Key, Terra Ceia, and Sarasota County