Axonics Modulation Technologies has received the US F ood and Drug Administration (F DA) 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.
“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.”
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. F aecal incontinence / accidental bowel leakage affects another estimated 40 million adults.