Genesis Spinal Cord Stimulation System Aids Patients Suffering from Chronic PainST. PAUL, Minn., Jan 18, 2010 (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(TM) spinal cord stimulation system for the management of chronic
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
The Genesis neurostimulator features:
Compact size (28 cc) which provides physicians flexibility in
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, 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 www.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.
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
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SOURCE: St. Jude Medical, Inc.
St. Jude Medical, Inc.
Sara Spafford Freeman, 651-756-6702
Denise Landry, 972-309-8085