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.
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.