Axonics Modulation Technologies said today that it won CE Mark clearance in the E.U. for its sacral neuromodulation external trial device.
The Irvine, Calif.-based company developed the first rechargeable sacral neuromodulation system for the treatment of urinary and bowel dysfunction, which won CE Mark approval in June 2016. Axonics’ external trial system is an additional element of the r-SNM system, designed to identify people who will respond to sacral neuromodulation therapy prior to a permanent implant.
The external trial device is a single-use, disposable stimulator that is connected to a tined lead or a temporary peripheral nerve evaluation lead, Axonics explained.
The company’s latest regulatory win comes as it readies for the commercial launch of its r-SNM system in the U.K. The company added that it expects additional regulatory approvals in the E.U. “in the near term,” including full-body MRI conditional labeling.
A 120-patient pivotal IDE trial is ongoing to support FDA approval for the r-SNM system in the U.S. for the treatment of urinary dysfunction.
“To date, over 225 patients have been implanted with an Axonics r-SNM System in Europe and North America, the vast majority of which without undergoing an external trial period before permanent implant. We demonstrated that with quality lead placement and confirmation of intraoperative responses, outstanding clinical results can be achieved without an external trial,” CEO Raymond Cohen said in prepared remarks.
“However, from a commercial standpoint, having an External Trial System is necessary given that payors prefer to reimburse permanent implants after confirming that the patient is a trial responder. We are confident that Axonics is now well positioned to capture significant worldwide share and, due to the benefits of our product offering, accelerate growth in the large $700 million Sacral Neuromodulation market.”