Medical devices giant,
St. Jude Medical
) has won CE Mark approval for its Brio Libra and LibraXP deep
brain stimulation ("DBS") product line. The devices are intended
to provide therapy for both primary and secondary dystonia.
Dystonia is an incurable neurological disorder disabling a
person's movement abilities. It is either hereditary (primary) or
acquired (secondary) from phenomenon such as stroke, brain
injury, trauma or pharmaceutical drugs. STJ is the pioneer in
achieving an approval from a regulatory body to treat both kinds
St. Jude had forayed into the European market with its Libra and
Libra XP DBS systems for treating Parkinson's disease in 2009.
Both the non-rechargeable DBS devices have better battery
capacity compared to other competitive offerings in the market.
In 2009, STJ had received CE Mark approval for its Brio
neurostimulator, the world's smallest, longest-lasting
rechargeable DBS device used for treating symptoms of Parkinson's
However, none of St. Jude's DBS systems are approved in the U.S.
but have received approval in Australia (apart from Europe) for
treating Parkinson's disease. In 2012, the Neuromodulation
business of St. Jude had received a warning letter from the FDA
for its migraine and Parkinson DBS products, resulting in a delay
in the launch of potential growth drivers. Management claims that
the inventory issue has been resolved and the business will be
back on track in 2013.
The U.S. IDE trial for Parkinson's disease using the DBS systems
is complete and the company expects to submit it for FDA
clearance in the second half of 2013. Meanwhile, St. Jude is
evaluating several new indications for the DBS devices, such as
depression and essential tremors.
St. Jude is a leading medical device manufacturer that designs,
manufactures and distributes medical devices to treat
cardiovascular and neurological conditions. We believe that the
European approval enhances the breadth of St. Jude's product
offerings in the deep brain stimulation systems and increases the
company's top-line. It affects about 500,000 people in Europe.
However, the product line is likely to face competition from
), also a provider of DBS therapy for Parkinson's disease,
essential tremor, and dystonia. It is the only company, which
offers FDA approved DBS systems for MRI head scans under specific
conditions of use.
St. Jude currently carries a Zacks Rank #4 (Sell). Softness in
the core Cardiac Rhythm Management ("CRM") market and the noise
surrounding its high-margin ICD leads are likely to keep revenues
under pressure. While we remain on the sidelines regarding STJ,
other medical products companies like
), with a Zacks Rank #1 (Strong Buy), warrant a look.
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