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Medtronic Initiates Clinical Study

Zacks Equity Research

Leading medical device player Medtronic Inc. (MDT) continues to focus on the promising neuromodulation business. The company recently started enrollment for a Prospective, Randomized Study of Multicolumn Implantable Lead Stimulation for Predominant Low Back Pain dubbed PROMISE.

The study will compare the performance of Specify 5-6-5 multicolumn surgical leads in conjunction with optimal medical management (:OMM), with the administration of only OMM in patients with failed back surgery syndrome (FBSS) and predominant low back pain. PROMISE is the first study to analyze the efficacy of Medtronic’s neurostimulation therapy (also known as spinal cord stimulation) on a large scale for chronic back pain. Earlier studies had focused predominantly on leg pain.

The PROMISE study is expected to support the use of Medtronic’s neurostimulation therapy in individuals who suffer from low back pain despite back surgery as oral medications may not provide sufficient relief to these patients. The study will enroll about 300 such individuals at 30 centers in the U.S., the U.K., Canada, Belgium, France, Germany, Spain and The Netherlands.

Medtronic’s neurostimulation therapy is a well-regarded treatment for chronic back and/or leg pain. According to the company, more than 250,000 individuals across the globe have benefited from the therapy.

According to a report from the Institute of Medicine, over 100 million U.S. adults suffer from chronic pain (as of Jun 2011) while data from European Journal of Pain suggests that one out of every five adults in Europe suffers from chronic pain (as of 2006). Research published by Pain Medicine journal shows that back pain, the most prevalent kind of chronic pain, affects the lives of 10% of the U.S. population. Further, the clinical studies in the journal revealed that oral medication and/or physical rehabilitation was not enough to improve the condition of FBSS patients.

Thus, FBSS patients need additional interventions. Medtronic’s neurostimulation therapy could just be the right treatment option for that. Positive results from the study and the subsequent commercialization should drive revenues for the company’s flourishing neuromodulation business.

The stock carries a short-term Zacks Rank #3 (Hold). Despite Medtonic’s effort to drive growth and profitability, currency headwinds and competitive landscape in the presence of large players like St. Jude Medical (STJ) and Boston Scientific (BSX) keeps us on the sidelines. Currently, these stocks also carry a Zacks Rank #3. However, neuromodulation company Cyberonics (CYBX) carries a Zacks Rank #1 (Strong Buy) and warrants a look.

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