St. Jude Medical Announces FDA Approval for Industry's Only MR-Conditional 5-Column Paddle Lead for the Management of Chronic...
20 July 2015 - 10:30PM
Business Wire
New MR-conditional labeling for the Penta paddle lead ensures
patients in need of future MRIs can access the industry’s broadest
paddle lead to support the treatment of chronic pain
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced U.S. Food and Drug Administration (FDA)
approval of MR-conditional labeling for the company’s Penta™
5-column paddle lead for spinal cord stimulation (SCS) therapy to
manage chronic pain. The Penta lead, which will be available for
use with the company’s Protégé MRI™ system in the U.S., is the only
five-column paddle lead on the market that will allow patients to
safely undergo head and extremity MRI scans.
For some chronic pain patients, the potential need for future
MRI scans has historically acted as a barrier to SCS therapy.
Throughout 2015, St. Jude Medical has introduced a series of
MR-conditional implantable pulse generators (IPG’s) and leads
designed to improve patient access to the latest chronic pain
therapy options while preserving the ability to undergo head and
extremity MRI scans.
With the newly approved updated labeling, the Penta paddle lead
will be available for use with the Protégé MRI system, which is the
smallest upgradeable MR-conditional SCS IPG available in the U.S.
In an SCS system, an IPG generates electrical energy, which is
delivered via leads to nerve fibers along the spine to interrupt
pain signals as they travel to the brain, reducing the sensation of
pain.
The St. Jude Medical Penta paddle lead is designed to provide
physicians the broadest area of lateral stimulation coverage
available (9mm), which supports selective stimulation of nerve
fibers associated with a patient's pain without needlessly
stimulating other areas. The broad coverage of the Penta
five-column paddle ensures sufficient stimulation when physicians
are faced with anatomical asymmetries or in cases where stimulation
is needed in very specific clusters of nerve fibers. Such specific
targeting allows physicians to tailor therapy to a patient’s unique
pain pattern.
"We are excited to receive MR-conditional labeling approval for
our Penta paddle lead alongside the recent approval of the Protégé
MRI system and MR-conditional labeling for our Octrode™
percutaneous leads,” said Eric S. Fain, M.D., group president of
St. Jude Medical. “When taken together, the approvals of these
products in our chronic pain portfolio represent a critical
component to growing our neuromodulation business and improving
access to our industry-leading chronic pain therapies for patients
who may need future head and extremity MRI scans.”
Chronic pain affects more than 100 million Americans, an
incidence rate which outpaces heart disease, cancer and diabetes
combined. In total, the condition costs the American population 515
million workdays annually and generates upwards of 40 million
visits to physicians each year. SCS therapy can offer proven,
meaningful chronic pain relief for many patients while improving
quality of life and reducing or even eliminating a patient’s use of
pain medication.
About the St. Jude Medical Chronic Pain PortfolioChronic
pain affects approximately 1.5 billion people worldwide, more than
heart disease, cancer and diabetes combined. The condition can
negatively impact mood, personal relationships, work productivity,
and activities of daily living. St. Jude Medical offers multiple
solutions for patients to manage debilitating chronic pain,
including spinal cord stimulation (SCS) and radiofrequency ablation
(RFA).
About St. Jude MedicalSt. 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 StatementsThis 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20150720005044/en/
St. Jude Medical, Inc.Investor RelationsJ.C. Weigelt,
651-756-4347jweigelt@sjm.comorMedia RelationsJustin Paquette,
651-756-6293jpaquette@sjm.com
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