SNS Vendors Move to Take Medtronic’s Market Share
by James Cavuoto, editor
February 2019 issue
The market for sacral nerve stimulation systems to treat bowel and bladder disorders has been dominated by Medtronic with its InterStim portfolio. But two new publicly traded U.S. firms are seeking to take SNS market share from Medtronic while several others are exploring other neuromodulation modalities. According to the Market for Neurotechnology: 2018-2022, the worldwide neuromodulation market for bowel and bladder disorders, which includes surface, implanted, and percutaneous devices, will grow from $831 million this year to $1.22 billion in 2022.
Nuvectra Corp., the Plano, TX manufacturer of neuromodulation systems that was spun off from Greatbatch Corp., recently announced that the FDA has extended its review of the company’s PMA application for its Virtis SNS system. Nuvectra CEO Scott Drees said that the FDA has not identified any deficiencies or requested any additional information. “The company is continuing to work closely with FDA to conclude our PMA review,” he said.
Meanwhile, Axonics Modulation Technologies, Inc., the Irvine, CA manufacturer of neuromodulation systems that spun out of the Alfred Mann Foundation, recently announced the submission of pivotal clinical data from the ARTISAN-SNM pivotal clinical study designed to gain FDA approval for the Axonics r-SNM system.
The ARTISAN-SNM study is a 129-patient single-arm, prospective, multi-center, unblinded pivotal clinical study approved under an FDA Investigational Device Exemption to evaluate the safety and efficacy of the r-SNM system for urinary dysfunction. The study was conducted in 14 centers in the U.S. and five centers in Western Europe. All patients reached their six-month, post-implant primary endpoint last month.
The clinical study demonstrated that patients implanted with the Axonics r-SNM system received clinically meaningful and statistically significant improvements in Urinary Urgency Incontinence symptoms and quality of life. Additionally, the study met all primary and secondary endpoints. No serious device-related adverse events have been reported.
While Nuvectra and Axonics will fight it out with Medtronic in the SNS space, several other vendors are looking to tibial nerve stimulation or other interventions to treat OAB and related disorders. Laborie (formerly Cogentix Medical) has been on the market with it percutaneous Urgent PC system, while StimGuard and BlueWind Medical are looking at injectable devices. Earlier this month, Bioness, Inc. announced that its StimRouter peripheral nerve stimulation system has received CE Mark approval for the treatment of OAB across Europe. StimRouter previously received CE Mark in 2014 for the treatment of chronic pain. Bioness is enrolling patients for a U.S. FDA IDE study to support the use of the system for the treatment of OAB in the U.S.
The StimRouter has the potential to meet a significant unmet medical need for people who are living with OAB as a permanent solution that includes the implant of a small, 15-cm insulated wire, and a wearable patch over the implant that powers the device and allows patients to control their symptoms by delivering pulses to the tibial nerve to reduce the chronic urge to urinate.
Another player, Minneapolis, MN-based FemPulse Corp., announced enrollment of the first patients at each of the centers participating in the company’s EVANESCE-OAB clinical trial. This study will evaluate the treatment of OAB in a home or at-work setting using the company’s device, the FemPulse system. The device is a non-implanted, vaginal ring intended to provide mild nerve stimulation to help regulate bladder sensation and relieve the symptoms of OAB. The device is a disposable, wearable device, which patients can place and remove on their own and control with a smartphone app. It delivers personalized, discreet therapy at a fraction of the cost of invasive, implantable systems.
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