St. Jude Medical Inc.
) revealed that it has received CE Mark approval for its Prodigy
implantable neuromodulation device that is capable of helping
patients suffering from chronic pain with reduced paresthesia
using Burst Technology. The company has launched the device in
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However, the news failed to entice investors as stock price fell
1.6% to $65.34. The lack of enthusiasm among investors may be
related to the fact that the device has not yet been approved in
the U.S. The company has received only Investigational Device
Exemption (IDE) from the U.S. Food and Drug Administration (FDA)
to evaluate the efficiency of burst stimulation in managing
chronic pain compared to traditional stimulation.
Traditional tonic spinal cord stimulation (SCS) subdues pain by
delivering equally spaced electrical pulses to nerve fibers and
thereby replaces pain with a tingling sensation called
paresthesia. However, the stimulation sensation can fluctuate
and, as a result, paresthesia may become uncomfortable for some
On the other hand, St. Jude Medical's Prodigy Chronic Pain System
is based on neurostimulation therapy in addition to Burst
Technology that sends intermittent "bursts" of stimulation,
The Prodigy device looks like a cardiac pacemaker with thin wires
and electrodes, delivering low power electrical energy to nerve
fibers. The electrical pulses intervene with the pain signals as
they travel to the brain, lowering painful sensations.
The Prodigy system has a lengthy battery life. Its small size
provides flexibility to physicians in choosing the implant
location and making the implant site less visible for patients
due to the need of a smaller incision.
One in five adults across Europe and more than 1.5 billion people
globally become affected by chronic pain. Despite being a severe
public health issue, it remains under-treated most of the time.
Recently, St. Jude Medical revealed that it has initiated
post-approval trial for the Nanostim leadless pacemaker in order
to evaluate the Nanostim leadless pacing technology. In this
LEADLESS Pacemaker Observational Study, St. Jude Medical will
enroll about 1,000 patients in nearly 100 centers in Europe.
Nanostim pacemaker obtained CE Mark approval in 2013. After its
approval, the pacemaker has been implanted in patients located in
the U.K., Germany, Italy, Czech Republic, France, Spain, and the
Currently, St. Jude Medical carries a Zacks Rank #2 (Buy). Other
preferable stocks in the medical products industry include
Meridian Bioscience, Inc.
). Enzymotec carries a Zacks Rank #1 (Strong Buy), while both
Meridian Bioscience and SurModics hold a Zacks Rank #2 (Buy).