STJ ST. Jude Medical, Inc.

Medical devices major St. Jude Medical (STJ) has won the European CE Mark approval for its Genesis neurostimulation system designed for peripheral nerve stimulation (“PNS”) of the occipital nerve (spinal nerve) for managing pain and disability associated with chronic migraine, a condition afflicting millions globally.

The 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.

Migraine is a debilitating condition which can last for hours or days. The condition is characterized by symptoms such as headache, sensitivity to light, noise and motion, nausea and vomiting. Chronic migraine represents a vastly unmet medical need. According to the World Health Organization (“WHO”), 10% of adults globally suffer from migraine.

The CE Mark approval was backed by the encouraging results from a large-scale clinical study (presented in June 2011), evaluating the effectiveness of the Genesis neurostimulator. The company-sponsored study, which was presented at the International Headache Congress in Berlin, Germany, demonstrated that PNS of the occipital nerve using 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.

The study followed 157 participants who suffered from headache 26 days in a month. These patients were implanted with the Genesis neurostimulator, and randomly assigned to an active or control group for 12 weeks. After one year, 65% of participants reported excellent or good pain relief.

St. Jude’s Neuromodulation division 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 the 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 in line with a short-term Zacks #3 Rank (Hold).

 
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