product approval introduction

Axonics® Announces U.S. Food & Drug Administration Approval for its Sacral Neuromodulation System for Urinary Clinical Indications

Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing novel implantable rechargeable sacral neuromodulation (“SNM”) devices for the treatment of bladder and bowel dysfunction, today announced the approval of the Axonics r-SNM® System by the United States Food & Drug Administration (“FDA”) for the clinical indications of overactive bladder (“OAB”) and urinary retention. The FDA premarket approval (“PMA”) grants Axonics the right to market its product in the United States for the clinical indications of OAB (urinary urge incontinence and urinary urge frequency) as well as urinary retention, representing the largest segment of the market for SNM devices. The FDA approval follows the Company’s September approval for the clinical indication of fecal incontinence, which, according to published clinical studies, is a co-morbidity reported by as many as a third of patients presenting with urinary urge incontinence. Read more.

Source: Business Wire, November 14 2019

product approval introduction

Axonics Sacral Neuromodulation for Urinary and Fecal Dysfunctions Cleared for MRI in Europe

Axonics, based in Irvine, California, won European regulatory approval for MRI conditional labeling for its sacral neuromodulation (SNM) system for treatment of overactive bladder, urinary retention, and fecal incontinence. The Axonics SNM system is now compatible, given certain precautions, with 1.5 Tesla and 3 Tesla MRI scanners. It is the only SNM system cleared in Europe with such labeling. The implant is rechargeable, and so can be used for much longer periods than similar devices that have to be replaced with fresh batteries. The company promises a lifetime of up to 15 years, Axionics claims is three times longer than Medtronic’s InterStim. Additionally, it’s 60% smaller. Read more.

Source: Medgadget, February 26, 2019

Intractable Urinary Incontinence Despite Treatments and Surgeries

My Story – Submitted by: Marguerite

I have suffered from intractable urinary incontinence for 20 years with many treatments and no success.   I have undergone the so-called gold standard Burch Procedure surgery during which time I acquired Clostridium difficile in the hospital.  I have had vaginal mesh surgery. I have  tried Medtronic’s Interstim implant in my buttocks to stimulate my sacral nerve (which later was removed as no longer functioning) and have had several infusions of botox in my bladder. I have had cocktails injected to treat (non existent) interstitial cystitis and now I rely on self-catheterization to Continue reading

Health Canada logo

Axonics Sacral Neuromodulation System Receives Marketing Approval

Axonics Modulation Technologies, Inc. announced today that it received a Homologation d’un instrument médical (medical device approval) for the first rechargeable Sacral Neuromodulation (r-SNM™) System® to treat Overactive Bladder (OAB), Fecal Incontinence and Urinary Retention.  The Health Canada license confirms that the Axonics® product meets all of the Canadian Medical Devices Regulations, Section 36, for Active Implantable Medical Devices and enables Axonics to market its r-SNM System throughout Canada. Read more.

Source: Yahoo! Finance, January 5, 2017

My Transvaginal Mesh Surgery

My Story – Submitted by: Mary

I am a 53-year old woman who had a hysterectomy for cervical cancer at 27 and chronic bronchitis in my 40’s. This caused my incontinence and I was told I would get relief if I had the transvaginal mesh implanted. I had the surgery in 2009, both bladder and rectal repairs.

Since then, I have had nothing but problems. The mesh is eroding out of my vagina, my bladder has fallen again, I cannot empty my bladder totally, have the urge to urinate often and I leak constantly. I also can’t be intimate with my husband without pain. That is not even close to being the worst of it.Continue reading

Overflow Incontinence

When you don’t feel the urge to urinate, the bladder may become overfilled, and urine may start to leak out. You may also not completely empty your bladder, causing urine to back-up and overflow. This condition is called overflow incontinence, or sometimes called “chronic retention of urine” or “chronic urinary retention”.Continue reading

Neurogenic Bladder

Drawing of a brain, spinal cord, and bladder

Damage to nerves may cause a neurogenic bladder.

Injuries, surgeries, diseases and birth defects may affect the how the body’s nerves work … or don’t work! Some medical conditions that commonly affect how our nerves work include Spina bifida, Multiple sclerosis (MS), Type 1 and 2 Diabetes, spinal cord injuries (SCIs), Parkinson’s disease, and stroke. And each of these conditions may create a neurogenic bladder.  A neurogenic bladder is a disorder of the lower urinary tract that is the result of damage to — or diseases of — the nervous system leading to a loss of voluntary control of your bladder.  Continue reading