Axonics Isn & #039;t Letting Medtronic Stand in Its Way

For 22 years, the world's largest pure-play medical device company was the only player in sacral neuromodulation, a space that addresses urinary problems as well as fecal incontinence. Now there's a new kid on the block, which has created quite an intense David vs. Goliath medtech story. For those unfamiliar with the Axonics vs. Medtronic story up to this point, click here for a quick rundown of recent events that have transpired in this market.   FDA Approves Second Indication for Axonics r-SNM FDA approved the urinary indications for an implantable rechargeable sacral neuromodulation (r-SNM) device developed by Axonics Modulation Technologies. The Irvine, CA-based company won FDA approval in September to market the device for the treatment of fecal incontinence. This second approval means the company can also market the device for urinary urge incontinence, urinary urge frequency, as well as underactive bladder or urinary retention. Both approvals also cover the claim of a 15-year functional life and the ability of patients to undergo full-body MRI scans without the necessity of having the device explanted. The device competes directly with Medtronic's InterStim II device, which has been the standard of care and used to treat more than 300,000 patients, according to Medtronic. The Axonics system is the first rechargeable SNM system approved in Europe, Canada, Australia, and now the United States.Â...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Implants Source Type: news