November 2019 issue
November 30, 2019 | The market for implanted sacral nerve stimulation devices to treat bowel and bladder disorders has become decidedly more competitive in recent weeks. Axonics Modulation Technologies received FDA approval for OAB for its rechargeable system and market-leader Medtronic responded with an announcement of its own rechargeable device and a patent infringement lawsuit against Axonics.
Earlier this month, Axonics announced FDA approval of the Axonics r-SNM system for the clinical indications of OAB and urinary retention. The approval follows the company’s September approval for fecal incontinence, which is a comorbidity reported by as many as a third of patients presenting with urinary urge incontinence. The FDA approval was supported by the results of a detailed review of technical data and the positive results of the Axonics ARTISAN-SNM 129-patient pivotal clinical study that met all primary and secondary endpoints and demonstrated 90-percent efficacy for all implanted urinary incontinence patients at six months, as well as published clinical literature.
Medtronic’s lawsuit alleges infringement of patents related to their minimally invasive sacral neuromodulation lead placement procedure and implant recharging technologies. The suit was filed in the U.S. District Court for the Central District of California, seeking injunctive relief and damages for infringement.
“Medtronic is the leader in minimally-invasive technology innovations in the field of sacral neuromodulation, making meaningful treatment options for people affected by bladder and bowel dysfunction,” said Brooke Story, vice president and general manager of the pelvic health and gastric therapies business, which is part of the Restorative Therapies Group. “Our many years of research and development in sacral neuromodulation, in partnership with physicians, has enabled us to create technology to improve the lives of hundreds of thousands of patients. We’ve developed various aspects of sacral neuromodulation and related technologies for decades, including percutaneous implantable delivery techniques, recharging technologies, as well as microstimulators. Our intellectual property is a critical component in making such advancements possible.”
Axonics quickly issued a statement denying the charges. “Axonics believes that this lawsuit is the kind of response that is all too predictable from Medtronic, signaling that it is lacking the wherewithal to compete fairly. It is ironic that the largest medical device company in the world, with over a 20-year long monopoly in the SNM market, failed to introduce any meaningful innovation for the sake of patients or their physician customers. Instead, they have chosen to employ legal tactics to engage in clear anticompetitive behavior and yet another attempt to change the dialogue with physicians and U.S. institutional investors,” said Axonics CEO Raymond Cohen.
Meanwhile, a potential third competitor in the SNS market, Nuvectra, will clearly be impacted by the company’s recent Chapter 11 filing [see article, p3]. It remains to be seen what will become of that firm’s Virtis device, which was still awaiting FDA approval at the time of the bankruptcy filing. But it seems likely that it may draw the attention of other medical device vendors that have yet to enter the SNS market. One potential buyer is Abbott, which is in close proximity to Nuvectra’s Plano, TX facilities and certainly has the funds for an asset sale. Another candidate is Biotronik, which is expected to enter the SCS market soon.
