St. Jude Medical Inc. STJ is expected to gain faster FDA approval for its Axium Neurostimulator System, on the back of impressive long-term data from the ACCURATE study. Data from the clinical study was recently presented at the 19th annual meeting of the North American Neuromodulation Society.
The Axium system, which targets stimulation of the dorsal root ganglion (DRG), is effective in treating patients with chronic pain. It is especially useful for treating pain that cannot always be addressed by traditional spinal cord stimulation (SCS) therapy.
Meanwhile, the long-term data from the ACCURATE study (largest clinical assessment for patients suffering from chronic lower limb pain) validated the superiority of the company’s Axium system over traditional SCS treatment. DRG stimulation delivered superior results compared to SCS on multiple grounds, after twelve months of the initiation of the study.
Firstly, patients who received DRG stimulation noted better pain relief and treatment success compared to SCS therapy. Secondly, patients treated with DRG stimulation reported enhanced stimulation targeting the pain area without extra paresthesia. Additionally, patients under the DRG stimulation group reported over 80% pain relief without paresthesia.
The Axium system is available in Europe since 2011. The company submitted its premarket approval to the FDA for DRG stimulation in the first quarter of 2015.
St. Jude Medical, along with other major medical device makers, has already been selling spinal cord stimulation devices that treat chronic pain conditions. However, the addition of the Axium Neurostimulator system has been a vital one, given the system’s ability to treat specific areas such as the foot, lower leg and groin.
Notably, the current market dynamics for pain management devices is quite lucrative. North America dominates the global market for pain management devices, advantaging from its large chunk of its aging population. St. Jude Medical should also benefit largely from its presence in the Asian market, as China and India are expected to be the fastest growing pain management device markets, going forward.
Zacks Rank & Key Picks
St. Jude carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the same space include Masimo MASI, Steris Plc STE and Natus Medical BABY. All the stocks sport a Zacks Rank #1 (Strong Buy).
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