Axonics Modulation Technologies has released topline clinical results from its ARTISAN-sacral neuromodulation (SNM) pivotal study. The Irvine, CA-based company’s Axonics r-SNM System was evaluated in a trial of 129 patients for the treatment of urinary and bowel dysfunction.
The study was conducted in 14 centers in the U.S. and five centers in Western Europe.
The two-year study results demonstrate that patients implanted with the Axonics r-SNM System continue to receive clinically meaningful and statistically significant improvements in urinary urgency incontinence symptoms and quality of life.
At two years, 88% of all implanted patients were therapy responders, consistent with the 89% therapy responder rate reported at one-year. About 80% of patients achieved >75% improvement, with 37% being completely dry. There were no serious adverse or unanticipated device-related events.
“The responder rate from the ARTISAN-SNM study continues to be the highest success rate reported in SNM literature and confirms sustained efficacy,” Karen Noblett, MD, a board-certified urogynecologist and CMO of Axonics, said in a release. “Americans with urgency incontinence are undertreated and struggle to find long-term relief. The persistent robust response and patient satisfaction with the Axonics r-SNM System demonstrates that there is an easy to use, highly efficacious treatment available to those suffering from this condition.”
Squaring Off in the Sacral Neuromodulation Market
Axonics has been embroiled in a patent lawsuit with Medtronic since late last year. The Dublin-based company was the only player in the sacral neuromodulation until Axonics received FDA approval for Axonics r-SNM System. The device competes directly with Medtronic's InterStim II device.
Medtronic initially alleged infringement of four patents related to its sacral neuromodulation lead placement procedure and implant recharging technologies. The medtech giant followed up a few weeks later adding three more patent infringement claims to the suit.
Earlier this year, Axonics fired back contesting the validity of each patent Medtronic accused it of infringing.