Spinal Cord Stimulators Reduce Opioid Use

By Pat Anson, Editor

Most patients who have a spinal cord stimulator significantly reduce their use of opioid pain medication one year after their implant, according to new industry-funded research.

In an analysis of private and Medicare insurance claims from 5,476 patients who received a spinal cord stimulator (SCS), opioid use declined or stabilized in 70 percent of the patients. Opioid use was higher among patients who had the stimulator removed.

The study, presented at the annual meeting of the North American Neuromodulation Society (NANS), was sponsored by Abbott (NYSE: ABT), a manufacturer of SCS systems and other medical devices.

"Given the epidemic of opioid addiction and abuse, these findings are important and confirm that spinal cord stimulation therapy can offer strong benefits for patients struggling with chronic pain," said Ashwini Sharan, MD, president of NANS and director of Functional and Epilepsy Surgery at Vickie and Jack Farber Institute for Neuroscience.

"Based on these results, we concluded it may be possible to improve outcomes by offering our patients spinal cord stimulation earlier, before opioid dependence and addiction can occur."

Spinal cord stimulators have long been considered the treatment of last resort for chronic back and leg pain, because the devices have to be surgically implanted near the spine and connected to batteries placed under the skin. The implants send electrical impulses into the spine to mask pain.

Some patients find the stimulators ineffective and have them removed. According to one study, only about half of patients who received a traditional SCS device have a 50 percent reduction in their back and leg pain.

New technologies have been developed to make the devices more effective, easier to recharge and to reduce complications such as paresthesia – a tingling or buzzing sensation.

And with government regulators and insurers discouraging the use of opioid pain medication, the medical device industry is urging patients and doctors to take another look at SCS devices.

X-RAY OF PATIENT WITH MEDTRONIC SCS DEVICE

"As our society has been seeking ways to stem opioid abuse and addition, our company offers treatment options that can reduce their exposure to opioid medication," said Allen Burton, MD, medical director of neuromodulation at Abbott in a news release. "Data like these are critical to helping us demonstrate that spinal cord stimulation can reduce exposure to opioids while giving patients comprehensive pain relief."

Abbot recently purchased St. Jude Medical, giving the medical device maker its first exposure to the SCS and neuromodulation market, which has an estimated value of $5.3 billion.

"Non-medical pain relief is a focus with attention on the dangers of pain medication and the need to find alternatives to reduce chronic pain," said Bruce Carlson, Publisher of Kalorama Information, a research firm that tracks the neuromodulation market. "Abbott builds on its cardiovascular device properties with this deal, and that is a big focus of press coverage.  St. Jude's impressive spinal cord offering should not be obscured in this transaction."

New Spinal Cord Stimulator Doesn’t Need Recharging

By Pat Anson, Editor

A new high-tech spinal cord stimulator is being launched in the U.S. and Europe, the first of its kind that doesn’t need recharging and can receive technology upgrades.

St. Jude Medical’s Proclaim Elite stimulator allows patients and clinicians to upload software upgrades to the device without surgery. Until now, most patients would require additional surgery to either update their devices or receive new ones. Unlike other spinal cord stimulators (SCS), the Proclaim Elite also doesn’t need recharging.

Stimulators are surgically placed near the spine and connected to batteries implanted under the skin. The devices send electrical impulses into the spine to mask pain.

“We developed the Proclaim Elite SCS system to create a more patient-centric spinal cord stimulation therapy option,” said Allen Burton, MD, medical director of neuromodulation and vice president of medical affairs at St. Jude Medical.

“The Proclaim Elite SCS system offers patients a combination of advanced pain therapy options and the convenience of a device that doesn’t require recharging, while removing barriers for future therapy and diagnostic options.”

The U.S. Food and Drug Administration approved the Proclaim Elite system earlier this month.

The device uses "burst" stimulation -- intermittent pulses of electrical energy that are designed to mimic the body’s natural nerve firing patterns. St. Jude says burst stimulation significantly reduces or eliminates paresthesia, the tingling sensation commonly associated with traditional SCS devices.

image courtesy st. jude medical

Many design elements of Proclaim Elite are based on physician and patient feedback. In particular, the non-rechargeable system removes the burden of patients needing to regularly recharge their SCS system. By providing access to both traditional SCS and burst stimulation in one system, the device gives an option to patients who don't initially respond to traditional therapy

“We’re seeing a shift in the SCS treatment paradigm as we move to a device that’s capable of delivering effective therapy tailored to a patient’s pain condition but that requires no device recharging,” said Frank Huygen, MD, an anesthesiologist and pain specialist from Erasmus MC Hospital in the Netherlands. “By combining burst stimulation and upgradeability in a non-rechargeable device, this innovative technology ensures physicians are more empowered to deliver therapy that can appropriately address our patient’s pain.”

The device uses Bluetooth wireless technology and Apple mobile devices for the patient controller and clinician programmer to improve interaction and allow for more effective management of chronic pain. Proclaim Elite also has conditional magnetic resonance (MR) labeling, which will allow patients to safely undergo MRI scans.

Chronic back pain is usually treated with physical therapy, pain relievers, injections or surgery. When those treatments fail, SCS devices are usually considered the treatment of last resort.

MarketsandMarkets, a market research firm based in Dallas, estimates the global market for spinal cord stimulators and other neuromodulation devices could reach $6.8 billion by 2017.