product approval introduction

InControl Medical Wins FDA Clearance for Attain: The First Over-the-Counter, At-Home Device for the Treatment of Urinary and/or Fecal Incontinence in Women

InControl Medical wins FDA clearance for new Attain, the first over-the-counter (OTC) non-implantable muscle stimulator designed for at-home use to help treat the approximately 60 million women in the U.S. suffering with stress, urge, mixed urinary incontinence and/or bowel incontinence.  This is good news for all those affected by urinary and/or involuntary bowel leakage that can increase with age: 20% -30% of young women, 30%-40% of middle-aged women, and up to 50% of older women suffer from incontinence.  It’s time to talk about this taboo topic before diapers become the newest accessory in the Nike store. So, strengthen your calves and abs, but don’t forget to strengthen your pelvic floor muscles too, says Lauren Streicher, M.D., Medical Director of the Northwestern Medicine Center for Sexual Health and Menopause and Clinical Professor of Obstetrics and Gynecology at Northwestern University. All kidding aside, many of my patients who suffer with urinary incontinence, can also have leaky bowel, and truly suffer in silence and embarrassment. Post-partum, anal or rectal cancer, and the natural aging process can cause incontinence. Thankfully, many patients respond well to pelvic-floor electrical stimulation and biofeedback as a first-line treatment, before considering surgery or medication. Attain is a small, painless, easy to use medical device for women to self-treat in the privacy of their own home, reducing or eliminating the need for pads or diapers. Read more.

Source: Global Banking & Finance Review, March 26, 2019

product approval introduction

Signal Catheter Prevents Injury from Premature Balloon Inflation

Safe Medical Design, a company based in San Francisco, CA, won FDA clearance for its Signal Catheter device. The indwelling foley urinary catheter is designed to help prevent discomfort and injury that can occur if it’s incorrectly placed, an all-too-common occurrence. Indwelling urinary catheters typically have a balloon at the tip that is inflated once it’s within the bladder. This prevents the catheter from sliding out. When the patient is “dry” and no urine is in the catheter, it’s often difficult to tell whether the catheter tip made it into the bladder, at times resulting in premature inflation that can cause serious trauma. The Signal Catheter is made of 100% silicone and it features a mechanism that relieves the pressure inside the balloon if it is improperly positioned and inflated inside the urethra. Read more.

Source: Medgadget, March 1, 2019

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InterStim Incontinence and Bladder Control Implant Now Controlled via App

Medtronic won FDA approval to introduce the InterStim smart programmer to control the company’s InterStim neurostimulation system used to manage overactive bladder, bowel incontinence, and some types of urinary retention.  The InterStim system delivers sacral neuromodulation therapy via an implant that looks similar to a cardiac pacemaker.  Read more.

Medgadget, December 17, 2018