St Jude Medical has received regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for the Genesis spinal cord stimulation system. The neurostimulation system is intended for the management of chronic pain.
Spinal cord stimulators are small implanted devices that are used for managing chronic pain of the back, arms and legs, including pain associated with back surgeries that have failed. Spinal cord stimulators, also known as neurostimulators, deliver mild electrical pulses to leads placed in the epidural space to interrupt or mask the transmission of pain signals to the brain.
The Genesis neurostimulator features include compact size (28 cc), which provides physicians flexibility in placement options, constant current stimulation for consistent delivery of therapy and maximum power output of 25.5mA (~12V) to address high energy needs.
Neurostimulation therapy provides patients with the opportunity to experience the therapy before moving forward with the permanent implant. Typically, the patient undergoes a minimally invasive outpatient procedure to determine if the therapy provides adequate relief. Following this short evaluation period, the physician and patient can decide to proceed with a permanent implant, said the company.
Genesis also allows patients the freedom to adjust their therapy as needed within parameters set by physicians. Each patient has a programmer that turns the system on and off and allows them to select from 24 different patient-specific customized stimulation programs, enabling them to manage their pain on a daily basis.
Chris Chavez, president of Neuromodulation division at St Jude Medical, said: “The launch of the Genesis system in Japan is a significant step in our continued international growth. We are excited to introduce our technology in Japan and to be able to provide a new option for physicians and patients that will help them manage the severest forms of chronic pain.”