Medical devices major St. Jude (STJ - Analyst Report) 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 - Analyst Report) and Boston Scientific (BSX - Analyst Report). 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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