FDA Nod for St. Jude Epiducer - Analyst Blog
July 13 2011 - 11:07AM
Zacks
Medical devices major St.
Jude (STJ) won the approval of
the U.S. Food and Drug Administration (“FDA”) for its Epiducer lead
delivery system.
This unique system has been geared
for neurostimulation therapy (stimulation of the spinal cord by
electrical impulses) for managing chronic pain. The Minnesota-based
company has begun a limited market launch of the
system.
The Epiducer system was designed to
reduce procedural complexities and improve efficiency in placing
neurostimulation leads used in spinal cord stimulation (“SCS”)
therapy for the management of chronic pain. This first-of-its-kind
system enables physicians to place multiple neurostimulation leads
through a single incision, allowing them to perform simpler, less
invasive procedures. Earlier, the placement of multiple leads
required several small incisions.
Chronic pain is a debilitating
condition that affects roughly 116 million adults in the U.S.,
according to Institute of Medicine (“IOM”) of the National
Academies. The annual cost associated with this condition has been
estimated at $100 billion. Chronic pain, which is long lasting or
recurring, is common in several back and spine conditions and is
often misdiagnosed. Poor prognosis of chronic back/spinal pain
typically leads to treatment failure.
SCS, an implantable
neurostimulation therapy, has a proven track record in providing
pain relief to patients and is primarily used for chronic pain
management when physical and/or drug therapies are ineffective.
Mild electrical impulses are delivered to the spinal cord that
interrupts pain signal transmission to the brain, thereby offering
relief.
The Epiducer system is the latest
addition to St. Jude’s neurostimulation product portfolio which
includes the Eon Mini SCS system, the world’s smallest,
longest-lasting rechargeable neurostimulator. It is already
marketed in Europe, Australia and Canada and is well received by
the physicians.
St. Jude’s Neuromodulation unit,
which was formed through its acquisition of Advanced
Neuromodulation Systems in November 2005, offers various
neurostimulation systems. The company is one of the three major
neurostimulation devices makers along with
Medtronic (MDT) and Boston
Scientific (BSX). More than 75,000 patients across 40
countries have been implanted with St. Jude’s neurostimulation
devices. We are currently Neutral on St. Jude, which is in tandem
with a short-term Zacks #3 Rank (Hold).
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