FDA Approves St. Jude’s iPad-Controlled Spinal Cord Stimulation System

The U.S. Food and Drug Administration has approved St. Jude Medical Inc.’s new Proclaim Elite Spinal Cord Stimulation system, an upgradeable and recharge-free spinal cord stimulation (SCS) product for chronic pain sufferers. The approval also includes conditional magnetic resonance (MR) labeling for the Proclaim Elite SCS system, which will allow patients to safely undergo head and extremity magnetic resonance imaging (MRI) scans.

Moreover, the current approval includes the company’s new clinician programmer, which allows clinicians to program and adjust their patient’s spinal cord stimulation therapy with an Apple iPad mini mobile digital device. In addition, patients will be able to evaluate spinal cord stimulation with the St. Jude Medical Invisible Trial System, a discreet, app-based and wireless neuromodulation programming system leveraging Apple iPad touch mobile digital devices.

“The approval of the Proclaim Elite recharge-free SCS system is a needed advancement for both patients and physicians who now have access to a low-maintenance chronic pain treatment that can reduce interference with daily activities,” said Timothy R. Deer, M.D., president and CEO of the Center for Pain Relief in Charleston, W.V. “In the last 10 years of SCS, we have seen advances in rechargeable technology but less attention paid to therapy compliance and how patients interact with their device. Now with the Proclaim Elite SCS system we can offer appropriate patients an optimal low-maintenance experience while enabling access to future therapies without the need for additional surgeries.”

According to the Institute of Medicine, chronic pain affects more than 100 million Americans, an incidence rate which outpaces heart disease, cancer and diabetes combined. Past research has suggested that the condition can cost the American population an estimated 515 million workdays annually and generates upwards of 40 million visits to physicians each year.

St. Jude Medical designed many elements of the Proclaim system based on both physician and patient feedback to ensure patients could benefit from all aspects of the product. In particular, the non-rechargeable system improves patient convenience by removing the burden of regularly recharging the SCS system. The system’s upgradable platform allows patients to access future SCS technology upgrades, such as new stimulation waveforms and software updates, without surgical device replacement, according to the company. Historically, most patients would need additional surgery to receive product upgrades as they are approved.

With its latest round of SCS product offerings, St. Jude Medical aims to further enhance ease-of-use and familiarity for patients by leveraging Bluetooth wireless technology and Apple mobile digital devices for the Proclaim Elite SCS system’s patient controller and clinician programmer. This approach allows patients to interact with their device more easily, which can ensure effective management of their chronic pain treatment with minimal disruption to their daily life.

“St. Jude Medical has a legacy of consistently advancing spinal cord stimulation therapy options to our ensure chronic pain patients are receiving innovative, patient-centric devices and optimal therapy to manage their chronic pain,” said Allen Burton, M.D., medical director of neuromodulation at St. Jude Medical. “The new St. Jude Medical Proclaim Elite system bridges the gap between today’s state-of-the-art therapies and tomorrow’s groundbreaking innovations for chronic pain. The wireless platform is based on the latest Apple technologies making it upgradeable to new therapies for the future. With a discreet, hassle-free trial system and a simple permanent implant procedure, this pioneering platform can improve both the patient’s chronic pain and overall therapy experience.”

Note: Apple, iPod touch and iPad Mini are trademarks of Apple, Inc. Bluetooth is a trademark of Bluetooth SIG, Inc.

Chronic pain affects approximately 1.5 billion people worldwide, more than heart disease, cancer and diabetes combined. The condition can negatively impact personal relationships, work productivity and a patient’s daily routine. St. Jude Medical is an international leader in the development of innovative chronic pain therapeutic options and offers multiple solutions for patients to manage debilitating chronic pain, including spinal cord stimulation, spinal cord stimulation targeting the DRG and radiofrequency ablation.