CE Mark for STJ's DBS Offering - Analyst Blog
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 of dystonia.
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 disease.
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 Medtronic ( MDT ), 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 Nuvasive ( NUVA ) and Conceptus ( CPTS ), with a Zacks Rank #1 (Strong Buy), warrant a look.
CONCEPTUS INC (CPTS): Free Stock Analysis Report
MEDTRONIC (MDT): Free Stock Analysis Report
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ST JUDE MEDICAL (STJ): Free Stock Analysis Report
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