On December 8, 2016, St. Jude Medical (STJ) announced CE Mark approval for full body MR (magnetic resonance) conditional labeling for the Proclaim Elite SCS (spinal cord stimulation) System. The approval marks a significant advancement in the company’s neuromodulation therapy area. St. Jude’s neuromodulation business generated around $141 million in sales in 3Q16. The business represents ~9.4% of the company’s total revenues with a YoY (year-over-year) growth rate of 17%. As we can see from the below diagram, the SCS portfolio generates the majority of St. Jude Medical’s neuromodulation revenues.
The system received full body MR conditional labeling approval in the Unites States in November 2016.
Boston Scientific (BSX) is St. Jude Medical’s biggest competitor in the neuromodulation space. Medtronic (MDT) is another major player in the market. In November 2016, Nevro (NVRO), a niche player in the neuromodulation market, filed a lawsuit against Boston Scientific claiming patent infringement on its patents for Senza and HF10 spinal cord stimulation therapies for chronic back pain. The Vanguard Total Stock Market ETF (VTI) holds ~0.10% of its total holdings in STJ.
The Proclaim Elite SCS system is a recharge-free device that features upgradeable solutions and wireless technology for a more superior therapy option for chronic pain patients. With the approval of the full body MR conditional labeling of the device, chronic pain patients that use the Proclaim Elite SCS system implant can undergo full body MRI (magnetic resonance imaging) scans. Thus, it enables such patients to retain access to treatments such as St. Jude Medical BurstDR stimulation with an additional upgrade of MR conditional labeling. This is the second upgrade for the device. The first upgrade was the approval for MR Conditional labeling for head and extremity MRI scans.
According to St. Jude Medical, “BurstDR stimulation is a physician-designed form of SCS clinically proven to provide patients superior pain relief (as compared to tonic stimulation) by reducing their physical pain and addressing their emotional response to pain as measured by visual analogue scale (VAS) scoring. Unlike other stimulation designs, St. Jude Medical BurstDR stimulation works differently, utilizing intermittent “burst” pulses designed to mimic the body’s natural nerve impulse patterns.”