St. Jude Wins FDA Approval for Device Using iPod

The minimally invasive spinal cord stimulator is meant to eliminate the need for complex controllers and bulky programming cables.

Nancy Crotti

An Apple a day might help keep the pain away. That's what St. Jude Medical's Invisible Trial System aims to do. The minimally invasive spinal cord stimulator, just approved by FDA, uses Bluetooth wireless technology and an Apple iPod Touch as the controller.

The device won the CE mark in Europe in June.

During a trial, a small implanted device and thin wires deliver low levels of electrical energy to mask or interrupt pain signals as they travel along nerve fibers to the brain. An external pulse generator, small enough to be worn under the patient's clothing, powers the system.

Physicians set the programming parameters on an iPad mini tablet, which displays usage data from the generator and allows the physician to print or email the data in PDF format.

The wireless system eliminates the need for complex controllers and bulky programming cables that can hinder a trial and dissuade patients from taking part in spinal cord stimulation therapy, according to a statement from Little Canada, MN-based company.

Smart devices are becoming used more commonly to facilitate patient-physician communication and treatment. A program in New Jersey is tracking breast cancer patients' treatment side effects, sleep information, physical activity levels, and patient mood using Apple Watches. The FDA granted AliveCor's smartphone-based heart monitor over-the-counter clearance last year. AliveCor uses U.S. board-certified cardiologists and U.S.-based cardiac technicians to analyze patients' data over the cloud to ensure that only important information and trends are carefully tracked. Worrisome data can be shared with the patient's personal physician. 

Research2guidance reported last year there were over 100,000 medical and health apps on Apple and Google's app stores. Google has reported that health and fitness have been the fastest growing category.

Nancy Crotti is a contributor to Qmed and MPMN.

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