Axonics Modulation Technologies has received the US Food and Drug Administration (FDA) approval for 3T full-body magnetic resonance imaging (MRI) conditional labelling for its r-SNM System under a premarket approval (PMA) supplement.
With the new approval, the device is the sacral neuromodulation (SNM) System available in the US with MRI compatibility for both 1.5T and 3T full-body scans.
The company acquired the regulatory approval for r-SNM System to treat faecal incontinence last year. It also received the European CE-Mark approval for MRI conditional labelling of the r-SNM System.
Axonics CEO Raymond Cohen said: “This FDA approval allows Axonics to provide healthcare professionals with more choices in selecting the optimal MR scanner for their patients’ imaging needs.
“We expect SNM to become the preferred therapy for patients suffering from overactive bladder and bowel dysfunction and we remain confident that our keen focus on innovation and increasing patient awareness will significantly expand the SNM market in the years ahead.”
Last month, Axonics was granted FDA approval for its SmartMRI wireless patient Remote Control for the r-SNM System.
Axonics focuses on developing implantable SNM devices for the treatment of urinary and bowel dysfunction.
These conditions significantly impact the quality of life and result from miscommunication between the bladder and the brain.
Almost 87 million adults in the US and Europe are estimated to suffer from overactive bladder. Faecal incontinence / accidental bowel leakage affects another estimated 40 million adults.