St. Jude Medical Announces Approval And Launch Of Neurostimulation System In Jap

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St. Jude Medical Announces Approval And Launch Of Neurostimulation System In

Japan

http://www.medicalnewstoday.com/articles/176371.php

St. Jude Medical, Inc. (NYSE:STJ) 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.

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 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 , 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 (ZephyrTM pacemaker, FrontierTM II CRT-P, CurrentTM

Implantable Cardioverter Defibrillator [iCD], PromoteTM Cardiac

Resynchronization Therapy Defibrillator [CRT-D], IsoFlexTM Pacing Leads,

TendrilTM ST OptimTM Pacing Lead, DurataTM Defibrillation Lead, and others)

- Products within the Atrial Fibrillation Division which aid physicians in

accessing, diagnosing and treating cardiac arrhythmias (EnsiteTM 3D Cardiac

Mapping System, InquiryTM Diagnostic Catheter IBI Ablation Catheter, SwartzTM

Braided Introducer, AgilisTM NxT Introducer, and others)

- Cardiology products for the diagnoses and treatment of cardiovascular and

valvular disease (SJM RegentTM Mechanical Heart Valve, SJM Rigid Saddle Ring,

SJM TailorTM Ring+Band, Angio-SealTM Evolution Vascular Closure Device, SignetTM

Pro PTCA Balloon Catheter, PressureWireTM, 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 http://www.PowerOverYourPain.com.