St. Jude Medical Announces Canadian Launch & First Implant of the Prodigy Spinal Cord Stimulation System with Burst Stimulation
May 19 2015 - 8:00AM
Business Wire
The Royal University Hospital in Saskatoon is Canada’s first to
implant the Prodigy system for the treatment of chronic pain
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced Health Canada approval and first implant
in Canada of its Prodigy™ Chronic Pain System with Burst
technology. The Prodigy system is the only implantable spinal cord
stimulation (SCS) system approved to deliver St. Jude Medical’s
proprietary Burst stimulation as well as traditional SCS to reduce
pain, improve patient satisfaction and eliminate paresthesia, the
tingling sensation commonly associated with traditional SCS, in
some patients.
A 52-year-old man from Saskatoon, received the Prodigy
neurostimulator on May 13 due to his experience with chronic pain
for several years following a successful trial experience and was
performed by Dr. Ivar Mendez, M.D., Ph.D, FRCSC, FACS, from
Saskatoon Health Region’s Royal University Hospital in
Saskatchewan, Canada.
Chronic pain affects one in five adults in Canada and more than
1.5 billion people worldwide, more than heart disease, cancer and
diabetes combined. The condition can negatively impact personal
relationships, work productivity and a patient’s daily routine, and
is a serious public health issue that remains largely under-treated
and misunderstood.
“Burst stimulation is a novel technology for SCS that has the
potential to be effective in patients that do not respond well to
traditional tonic stimulation. Studies have shown that with Burst
stimulation patients can experience reduced paresthesia and pay
less attention to their pain improving their overall experience
with SCS therapy,” Mendez said, who is chairman of the Department
of Surgery at the University of Saskatchewan and the Saskatoon
Health Region’s Royal University Hospital. “SCS therapy can provide
significant pain relief and thus enable many patients to increase
their activity levels and improve their overall quality of life. In
combination with conventional tonic stimulation, Burst stimulation
represents a comprehensive approach to effective pain management
and allows me to tailor the therapy to my patient’s unique
situation.”
SCS therapy uses an implanted pulse generator and thin wires
with electrodes to deliver low levels of electrical energy to nerve
fibers. These electrical pulses mask or interrupt pain signals as
they travel to the brain, reducing the sensation of pain.
Traditional tonic stimulation uses equally spaced electrical pulses
to replace pain with a tingling sensation called paresthesia. For
some patients, the stimulation sensation can fluctuate with changes
in body position and paresthesia may become uncomfortable.
St. Jude Medical’s Burst stimulation works differently, and
offers intermittent “bursts” of stimulation, designed to mimic the
human body’s natural design of neuron signaling and thus provide an
alternative therapy method for chronic pain conditions. In
addition, Burst stimulation has been shown to significantly reduce
or eliminate paresthesia. The ability to support two modes of
stimulation provides clinicians with the opportunity to more
effectively adjust the therapy to a patient’s unique pain condition
and may be especially helpful over time.
The Prodigy system features the longest-lasting battery life of
all rechargeable SCS devices approved for use in Canada and, unlike
some competitive devices, does not include a manufacturer-induced
device shut-off. Additionally, its small size allows for a smaller
incision, which gives physicians increased flexibility in selecting
the implant location and is intended to make the site less visible
and more comfortable for patients.
Through an Investigational Device Exemption (IDE) from the U.S.
Food and Drug Administration (FDA), the St. Jude Medical study
called SUNBURST™ (Success Using Neuromodulation with BURST) is
evaluating whether Burst stimulation can be more effective in
managing chronic pain than traditional tonic stimulation. The
Prodigy neurostimulator is not approved for use in the U.S.
About St. Jude Medical
St. Jude Medical is a global medical device manufacturer
dedicated to transforming the treatment of some of the world’s most
expensive epidemic diseases. The company does this by developing
cost-effective medical technologies that save and improve lives of
patients around the world. Headquartered in St. Paul, Minn., St.
Jude Medical has four major clinical focus areas that include
cardiac rhythm management, atrial fibrillation, cardiovascular and
neuromodulation. For more information, please visit sjm.com or
follow us on Twitter @SJM_Media.
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 Annual Report on Form 10-K for the fiscal year ended
January 3, 2015 and Quarterly Report on Form 10-Q for the fiscal
quarter ended April 4, 2015. The Company does not intend to update
these statements and undertakes no duty to any person to provide
any such update under any circumstance.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20150519005300/en/
St. Jude Medical, Inc.Investor RelationsJ.C. Weigelt,
651-756-4347jweigelt@sjm.comorMedia RelationsBarbara Van Buyten,
+32 473 55 34 82bvanbuyten@sjm.com
SJM (NYSE:STJ)
Historical Stock Chart
From Apr 2024 to May 2024
SJM (NYSE:STJ)
Historical Stock Chart
From May 2023 to May 2024