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University of Florida Health patient is first in the state to get new pain relief implant

Two men sitting in chairs side by side and smiling
Two men sitting in chairs side by side and smiling

For decades, chronic back pain dominated Felix Favicchio’s life. On most nights, sleep came fitfully. Simply lying in bed brought searing torment. His days weren’t much better.

“On a good day, I would try to get up and do something. I would have to go back in the house. I couldn’t do anything because of the pain,” the 58-year-old said.

All of that changed Sept. 27, when Favicchio became the first person in Florida to receive a new neurostimulation implant for people living with chronic back pain. The outpatient procedure was performed at University of Florida Health by anesthesiologist Ajay B. Antony, M.D. Abbott’s Proclaim XR system was approved in late September by the U.S. Food and Drug Administration following study results issued in January.

Neuromodulation works by delivering low doses of mild electrical pulses to change pain signals as they travel from the spinal cord to the brain. What makes the Proclaim XR system different is its longevity: Doctors can find the lowest effective dose of stimulation, which allows the spinal cord stimulation device to remain powered for up to 10 years. With other neurostimulation devices, patients are tethered to a recharging system while the battery replenishes.

Neurostimulation has another advantage: less reliance on opioid pain medications. More than 30 percent of Americans have chronic and acute pain, according to The New England Journal of Medicine. Neurostimulation devices can reduce dependence on opioids for chronic pain management and prevent the need for increasingly larger doses of pain medication.

“Proclaim XR is the latest data-driven advancement in patient-centric pain therapy — opening the doors for people who don’t want to be burdened with the hassles of recharging. Recharge-free means patients can live their lives without the constant reminder of being in treatment,” said Keith Boettiger, vice president of Abbott’s neuromodulation business.

Favicchio has spent most of his adult life battling back pain. It started with an injured spinal disk after a construction accident at age 24. Over the years, he tried everything to get relief — surgeries, rehabilitation, opioid pain relievers, massage therapy and muscle relaxants. Favicchio was cautious with the painkillers: They didn’t seem to help much and he was concerned about the potential for addiction. On a scale of 1 to 10, the pain was a constant 7, he said.

The pain also intruded in other parts of his life: Favicchio and his wife, Josephine, used to walk 3 miles a night. That eventually ended, along with the gardening Felix enjoys so much.

“He wasn’t happy, so I wasn’t happy,’’ Josephine said. “The pain changed his whole demeanor.”

In July, things got worse. Favicchio was involved in a hit-and-run car crash that made his back pain spike.

“It was out of control — a shooting pain from my neck all the way down to my feet,” he said.

After testing Burst DR stimulation on a trial basis and finding that it gave Favicchio some relief, Antony moved ahead with a permanent implant of the Proclaim XR.

During a 90-minute procedure, two small incisions were made to place a small device called an implantable pulse generator in Favicchio’s lower back. Thin, insulated wires from the device were then guided into the epidural space of the spine. The patient receives only light sedation, similar to what is used during a colonoscopy.

The Proclaim XR is a result of advances in neuromodulation research and technology, said Antony, an assistant professor in the UF College of Medicine’s anesthesiology department. Delivering smaller electrical pulses gives high-quality pain relief to patients while also allowing the devices to last for years without recharging. The Proclaim also is more inconspicuous for patients: New technology means they no longer feel a tingling sensation as the device works to block pain signals.

“The goal is to decrease pain and, more importantly, allow patients to do things that they enjoy or haven’t been able to do before. The fact that Felix won’t have to spend time maintaining a device allows him to accomplish his goal of being more active,” Antony said.

On Oct. 2, Favicchio’s neuromodulator was activated for the first time. Using an Apple iPad mini and a proprietary app, Abbott territory manager Dallas Graham customized the settings to begin delivering pain relief. Tell me when you start to feel some relief, she told Favicchio.

“The pain. It’s going away. This is what I always wanted,” Favicchio said.

Using the iPad, Graham adjusted the amplitude, or intensity, of the neurostimulation. As the pain he had known for decades began ebbing, a smile crossed his face.

“It’s like putting water on a fire,” he said.

While the device might not completely end a patient’s pain, Antony said it provides a meaningful reduction that will unquestionably improve the quality of life for Favicchio and other patients with chronic pain. Patients are now reaping the benefits of recent technological advances in neuromodulation pain relief, Antony said. The device’s arrival is also encouraging because research shows that spinal cord stimulation reduces patients’ need for opioid pain relievers, he added.

“We are now capable of treating a larger number of patients and providing a higher degree of pain relief. University of Florida Health has been a leader in advancing the field,” he said.

A week after the implant was activated, Favicchio was able to stop taking his medication for nerve pain. The pain dropped to 1 on the 1 to 10 scale.

“I’m sleeping better. I have a lot more energy. I feel like a brand-new person,” he said.

His wife is already making plans. Felix can finally finish the tile in their house near Gainesville and get back to tending his garden.

“We’re looking forward to getting back to our normal life,” she said.

About the author

Doug Bennett
Science Writer, Editor

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