Axonics Modulation Technologies (NSDQ:AXNX) announced positive top-line results from a pivotal study of its novel implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction.
The clinical study demonstrated that patients implanted with the Axonics r-SNM system experienced clinically meaningful and statistically significant improvements in urinary urgency incontinence (UUI) symptoms and quality of life, according to the Irvine, Calif.-based company. The study also met all secondary endpoints, and no serious device-related adverse events were reported.
The129-patient, single-arm, prospective, multi-center, unblinded pivotal clinical study was approved under an FDA Investigational Device Exemption (IDE). It was conducted in 14 centers in the U.S. and five centers in Western Europe.
All patients were implanted with a tined lead and the Axonics neurostimulator. Investigators collected efficacy data using a three-day bladder diary, a validated quality of life questionnaire, and a satisfaction questionnaire. Patients with at least 50% reduction in urgency incontinence episodes at follow-up visits as compared to baseline were considered therapy responders.
At six months, 90% of all implanted patients were therapy responders, including 80% of therapy responders with a ≥75% reduction in urgency incontinence episodes of which 34% were completely dry. Across all patients, urgency incontinence episodes per day dropped from 5.6 ± 0.3 (mean ± standard error) at baseline to 1.3 ± 0.2 at six months (p<0.0001). Patients averaged statistically and clinically significant improvement on the quality-of-life questionnaire score (34 points) at six months as compared to baseline and 93% of all implanted patients reported satisfaction with their r-SNM therapy.
“This successful clinical study marks an important milestone on our path to gaining FDA approval,” said Axonics chief medical officer Karen Noblett, M.D., in a prepared statement. “Historically, SNM therapy has only been available with a non-rechargeable implanted neurostimulator with an average lifespan of four years, requiring replacement surgery due to depletion of the neurostimulator battery. We believe that, in addition to reducing costs for patients and payors, the miniaturized 5cc rechargeable Axonics system, qualified to last in the body for at least 15 years, can significantly increase adoption of SNM therapy.”
Axonics filed a premarket approval application and interim clinical data from the study with FDA in December 2018. The company said it intends to file the six-month clinical data with the agency this week.
|
Tell Us What You Think!