St. Jude Medical's Prodigy Neurostimulator Gets CE Mark - Analyst Blog

St. Jude Medical Inc. (STJ) revealed that it has received CE Mark approval for its Prodigy implantable neuromodulation device that is capable of helping patients suffering from chronic pain with reduced paresthesia using Burst Technology. The company has launched the device in Europe.

However, the news failed to entice investors as stock price fell 1.6% to $65.34. The lack of enthusiasm among investors may be related to the fact that the device has not yet been approved in the U.S. The company has received only Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to evaluate the efficiency of burst stimulation in managing chronic pain compared to traditional stimulation.

Traditional tonic spinal cord stimulation (SCS) subdues pain by delivering equally spaced electrical pulses to nerve fibers and thereby replaces pain with a tingling sensation called paresthesia. However, the stimulation sensation can fluctuate and, as a result, paresthesia may become uncomfortable for some patients.

On the other hand, St. Jude Medical’s Prodigy Chronic Pain System is based on neurostimulation therapy in addition to Burst Technology that sends intermittent “bursts” of stimulation, minimizing paresthesia.

The Prodigy device looks like a cardiac pacemaker with thin wires and electrodes, delivering low power electrical energy to nerve fibers. The electrical pulses intervene with the pain signals as they travel to the brain, lowering painful sensations.

The Prodigy system has a lengthy battery life. Its small size provides flexibility to physicians in choosing the implant location and making the implant site less visible for patients due to the need of a smaller incision.

One in five adults across Europe and more than 1.5 billion people globally become affected by chronic pain. Despite being a severe public health issue, it remains under-treated most of the time.

Recently, St. Jude Medical revealed that it has initiated post-approval trial for the Nanostim leadless pacemaker in order to evaluate the Nanostim leadless pacing technology. In this LEADLESS Pacemaker Observational Study, St. Jude Medical will enroll about 1,000 patients in nearly 100 centers in Europe.

Nanostim pacemaker obtained CE Mark approval in 2013. After its approval, the pacemaker has been implanted in patients located in the U.K., Germany, Italy, Czech Republic, France, Spain, and the Netherlands.

Currently, St. Jude Medical carries a Zacks Rank #2 (Buy). Other preferable stocks in the medical products industry include Enzymotec Ltd. (ENZY), Meridian Bioscience, Inc. (VIVO) and SurModics, Inc. (SRDX). Enzymotec carries a Zacks Rank #1 (Strong Buy), while both Meridian Bioscience and SurModics hold a Zacks Rank #2 (Buy).
 

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