St. Jude's Protege Wins FDA Approval - Analyst Blog

St. Jude Medical Inc. STJ revealed that its Protégé spinal cord stimulator received pre-market approval from the U.S. Food and Drug Administration (FDA). The Protégé stimulator helps alleviate chronic pain by interfering with the transmission of pain signals using electrical pulses.

The Protégé spinal cord stimulator is the first neurostimulation system, which can be upgraded without the need of a surgical replacement of the device. The upgrades provide access to therapies, stimulation modes, diagnostics or other features through software upgrades.

Last month, St. Jude Medical 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.

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.

In the same month, St. Jude Medical also 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, Covidien plc COV and William Demant Holding A/S (WILYY). Enzymotec carries a Zacks Rank #1 (Strong Buy), while both Covidien and William Demant Holding hold a Zacks Rank #2 (Buy).