The St. Jude Medical Invisible Trial System has cleared the FDA hurdle, the company has announced. The wireless system, which received CE Mark in June 2015, is designed to provide patients a more improved and discreet spinal cord stimulation (SCS) trial experience.
The SCS therapy can be an effective option for managing chronic pain for many patients. The therapy relies on a small implanted device and thin wires (known as leads) to deliver low levels of electrical energy to mask or interrupt pain signals as they travel along nerve fibers to the brain, which reduces the sensation of pain. Prior to receiving a permanently implanted SCS device, patients undergo a minimally invasive “trial” period to evaluate the therapy. Yet for some patients, complex controllers and bulky programming cables can disrupt the trial experience and act as barrier to SCS therapy.
The Bluetooth-enabled Invisible Trial System removes these barriers by providing patients with a more intuitive iPod touch as a controller, while allowing physicians to utilize an iPad to program and evaluate their patient’s therapy.
St. Jude Medical’s system feels essentially “invisible” to the wearer, providing a more comfortable trial experience.“By providing a discreet trial system, St. Jude Medical will help patients focus more on their potential pain relief and functional improvements, and less about the burdens common to traditional trial systems,” said pain specialist Dr. Jason E. Pope, president of Summit Pain Alliance in Santa Rosa, California.
The St. Jude Medical Invisible Trial System uses a small external pulse generator (EPG) as the system’s power source, enabling a small, easy-to-carry around device profile. The effect is that the system feels essentially “invisible” to the wearer, providing a more comfortable trial experience that allows patients to focus entirely on their system’s therapeutic impact during their trial.