St. Jude Medical's Prodigy Neurostimulator Gets CE Mark - Analyst Blog
March 26 2014 - 4:00PM
Zacks
St. Jude Medical Inc. (STJ) 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 Europe.
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 patients.
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,
minimizing paresthesia.
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
Netherlands.
Currently, St. Jude Medical carries a Zacks Rank #2 (Buy). Other
preferable stocks in the medical products industry include
Enzymotec Ltd. (ENZY), Meridian
Bioscience, Inc. (VIVO) and SurModics,
Inc. (SRDX). Enzymotec carries a Zacks Rank #1 (Strong
Buy), while both Meridian Bioscience and SurModics hold a Zacks
Rank #2 (Buy).
ENZYMOTEC LTD (ENZY): Free Stock Analysis Report
SURMODICS (SRDX): Free Stock Analysis Report
ST JUDE MEDICAL (STJ): Free Stock Analysis Report
MERIDIAN BIOSCI (VIVO): Free Stock Analysis Report
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