ST. PAUL, Minn.–(BUSINESS WIRE)–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.
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 (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, InquiryTMDiagnostic 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 TailorTMRing+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 atwww.PowerOverYourPain.com.
About St. Jude Medical
St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. Headquartered in St. Paul, Minn., St. Jude Medical employs more than 14,000 people worldwide and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com.
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Quarterly Reports on Form 10-Q for the fiscal quarters ended April 4, 2009, July 4, 2009 and October 3, 2009. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
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