Japanese MHLW approves St. Jude Medical's Genesis spinal cord stimulation system

Jan 18 2010

St. Jude Medical, Inc. (NYSE:STJ) today announced regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for the Genesis™ spinal cord stimulation system for the management of chronic pain.

“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.”

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 launch of the Genesis system in Japan is a significant step in our continued international growth,” said Chris Chavez, president of the St. Jude Medical Neuromodulation Division. “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.”

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

Neurostimulation therapy is unique in that it 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.

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 customized stimulation programs, enabling them to manage their pain on a daily basis.

“Japan represents the second-largest market for medical devices in the world,” said William Phillips, president of St. Jude Medical Japan. “We are excited to be able to add a neurostimulation system to the growing line of medical products that we provide to physicians to meet the varying needs of patients.”

The launch of the Genesis neurostimulation system in Japan adds to the portfolio of products available to physicians from St. Jude Medical Japan. Others include:

• Cardiac Rhythm Management devices for the treatment of abnormal heart rhythms and heart failure (Zephyr^TM pacemaker, Frontier^TM II CRT-P, Current^TM Implantable Cardioverter Defibrillator [ICD], Promote^TM Cardiac Resynchronization Therapy Defibrillator [CRT-D], IsoFlex^TM Pacing Leads, Tendril^TM ST Optim^TM Pacing Lead, Durata^TM Defibrillation Lead, and others)
• Products within the Atrial Fibrillation Division which aid physicians in accessing, diagnosing and treating cardiac arrhythmias (Ensite^TM 3D Cardiac Mapping System, Inquiry^TM Diagnostic Catheter IBI Ablation Catheter, Swartz^TM Braided Introducer, Agilis^TM NxT Introducer, and others)
• Cardiology products for the diagnoses and treatment of cardiovascular and valvular disease (SJM Regent^TM Mechanical Heart Valve, SJM Rigid Saddle Ring, SJM Tailor^TM Ring+Band, Angio-Seal^TM Evolution Vascular Closure Device, Signet^TM Pro PTCA Balloon Catheter, PressureWire^TM, Certus FFR Measurement System, and others)

Chronic pain is a largely under-treated and misunderstood condition that affects millions of patients worldwide. The World Health Organization, in conjunction with the International Association for the Study of Pain (IASP), reports that as many as one in five people suffers from moderate to severe chronic pain.

More than 60,000 patients in 35 countries have been implanted with St. Jude Medical neurostimulation systems. Patients can obtain more information about neurostimulation therapy at www.PowerOverYourPain.com.

SOURCE St. Jude Medical