STJ ST. Jude Medical, Inc.

Medical devices major St. Jude Medical (STJ) presented encouraging results from a large-scale clinical study evaluating the effectiveness of an implantable device developed by the company in treating chronic migraine, a condition afflicting millions globally. 

Migraines are estimated to affect roughly 28 million Americans. It is a debilitating condition which can last for hours or days. Migraine is characterized by symptoms such as headache, sensitivity to light, noise and motion, nausea and vomiting. Chronic migraine represents a vastly unmet medical need.

The company-sponsored study, which was presented at the International Headache Congress in Berlin, Germany, demonstrated that peripheral nerve stimulation (“PNS”) of the occipital nerve using the company’s implanted device was safe and effective in reducing the number of migraine headache days per month and helped improve patient quality of life.

The study followed 157 participants who suffered from headache 26 days per month. These patients were implanted with the company’s implantable device, the Genesis neurostimulator, and randomly assigned to an active or control group for 12 weeks. At one year, 66% of participants reported excellent or good pain relief.

The trial showed statistically significant results, including 28% reduction in the number of headache days in patients receiving stimulation, versus the placebo group which reported a 4% reduction.

St. Jude’s Genesis neurostimulation system works by delivering mild electrical pulses to leads placed under the skin at the back of the head, stimulating the occipital nerves. The company has submitted for CE Mark approval of the Genesis system for managing pain and disability associated with chronic migraine.

St. Jude expects to commence a limited launch of the device for this indication in Europe in late-2011. However, the company is unclear, at this moment, about the timing of the U.S. approval of the Genesis neurostimulator for the management of chronic migraine.

St. Jude’s Neuromodulation division, which was formed through its acquisition of Advanced Neuromodulation Systems in November 2005, offers various neurostimulation systems. The company is one of the three major manufacturers of neurostimulation devices along with Medtronic (MDT) and Boston Scientific (BSX). More than 75,000 patients across 40 countries have been implanted with St. Jude’s neurostimulation devices.

The neurostimulation market is growing at a healthy pace driven by growth in age-related neurological conditions and significant need for effective alternative therapies. This market is forecasted to grow 15% annually, offering a compelling prospect for the incumbent players. Currently, we have a Neutral recommendation on St. Jude, which is supported by a short-term Zacks #3 Rank (Hold).

 
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