Medical devices major,
St. Jude Medical, Inc.
) recently announced results from a large-scale clinical study of
peripheral nerve stimulus (PNS) of the occipital nerve for managing
pain and disability associated with chronic migraine, a condition
afflicting millions globally. St. Jude's Genesis neurostimulation
system was used for this study.
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The results, published online by
, the journal of the International Headache Society (IHC),
demonstrate that the device was safe and effective in reducing the
number of migraine headache days per month and helped improve a
patient's quality of life. Earlier in June 2011, encouraging
preliminary results from this study were presented at the IHC,
which also reported PNS therapy to be beneficial.
The Genesis neurostimulation system works by delivering mild
electrical pulse to leads placed under the skin at the back of the
head, stimulating the occipital nerves. The device has already
received European as well as Australian approval to treat patients
with intractable chronic migraine.
Per the results of the clinical study, 157 patients treated across
15 medical centers in the U.S., with severe headache for roughly 21
days per month, reported an average of 6 lesser headache days per
month after receiving the PNS therapy for 12 weeks. Moreover,
disability score improved by 43% based on the Migraine Disability
Assessment questionnaire (MIDAS).
In addition, participants reported 42% advancement in pain relief
and 52% rated their relief as either good or excellent. However,
adverse effects such as pain and/or numbness at the implant site,
succeeded by lead migration plagued some of the patients.
Nonetheless, these were classified as mild or moderate in terms of
severity in most of the cases.
The Genesis system earlier was a part of the Neuromodulation
("NMD") business of St. Jude. However, the company recently
combined its Cardiac Rhythm Management ("CRM") Division and the NMD
Division to form the Implantable Electronic Systems Division
("IESD"). The latest positive data from the study regarding Genesis
neurostimulators are likely to further boost IESD's product sales.
St. Jude's Neuromodulation revenues are growing steadily,
benefiting from new spinal cord and Parkinson's disease devices as
well as sustained adoption of the Eon Mini implantable
neurostimulator. In the last reported second quarter of 2012,
Neuromodulation sales increased 2%, (up 5% in constant currency)
year over year to $106 million.
With a market cap of $13.63 billion, St. Jude is a leading medical
device manufacturer with a solid rate of growth over the past
decade. We are impressed by its solid fundamentals, healthy growth
trajectory, strong product mix, robust pipeline and cost management
While a host of new growth drivers, including new products and cost
saving measures, are expected to boost results in 2013 and beyond,
we remain cautious about the increased competition, weakening Euro,
the soft CRM market and the overall tough macroeconomic conditions.
A still choppy CRM space overhangs on St. Jude and its peers
Boston Scientific Corporation
). We currently have a Neutral recommendation on St. Jude, which
carries a short-term Zacks #3 Rank (Hold rating).