St. Jude Medical is set to introduce its neurostimulation system in Japan. The company has gained regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for its Genesis spinal cord stimulation system.
Spinal cord stimulators are small implanted devices that are used for managing chronic pain of the back, arms and legs. 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 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 customised stimulation programmes, enabling them to manage their pain on a daily basis.
Chris Chavez, president of the St. Jude Medical Neuromodulation Division, mentioned that the development supports company’s international growth plan.
The Genesis neurostimulator features:
Compact size (28 cc) which provides physicians flexibility in placement options
Constant current stimulation for consistent delivery of therapy
Maximum power output of 25.5mA (~12V) to address high energy needs
The company is already selling following products in Japan: Cardiac Rhythm Management devices for the treatment of abnormal heart rhythms and heart failure; Products within the Atrial Fibrillation Division which aid physicians in accessing, diagnosing and treating cardiac arrhythmias; Cardiology products for the diagnoses and treatment of cardiovascular and valvular disease.
