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| Poise Impressa--Courtesy of Kimberly-Clark |
Kimberly-Clark ($KMB) announced that the first internal over-the-counter device cleared for temporary management of stress urinary incontinence is launching in retail stores across the U.S.
The Poise Impressa Bladder Supports offer women a nonsurgical, nonprocedural option to treat the condition, which results from weak muscles around the bladder and causes urine leakage.
"As about 80 percent of stress urinary incontinence sufferers do not wish to be operated on or are not eligible for an operation, Impressa is positioned as a product that fills the gap in the stress urinary incontinence landscape between conservative treatment options and more invasive procedures," product developer and urogynecologist Dr. Elan Ziv told Reuters. Ziv is the CEO of Israel's ConTIPI Limited, which sold the device to consumer products giant Kimberly-Clark after securing FDA clearance in 2013.
The Impressa is described by the FDA as a vaginal pessary. But unlike other vaginal pessaries that are designed to be used for days or weeks, the Impressa is worn for 8 hours, meaning it does not to be removed and cleaned. Most importantly, the device is inserted into the vagina similar to a tampon--without the assistance of a doctor. It does not absorb leaks; instead it prevents them from occurring, Kimberly-Clark says in a release.
"We know consumers want to manage their bladder leakage in a way that allows them to live their most active, worry-free life," said Kimberly-Clark's Paula Winkel, a senior director of research and engineering, in a statement. "By effectively translating deep consumer insights, we've introduced an innovation with Poise Impressa that changes the game in the light incontinence category."
In 2013 a study of 60 women with urinary stress incontinence designed to gain FDA clearance, 85% demonstrated a reduction in leakage, reports Reuters.
The Impressa has been available online since February. Now Kimberly-Clark is expanding access to include retail outlets around the country. Kimberly-Clark spun off its $1.6 billion healthcare business in November, creating Halyard Health, a company focused on pain management products, surgical and infection protection, surgical solutions, respiratory health and digestive health products.
But Impressa shows that med tech has a role to play in Kimberly-Clark's bread-and-butter consumer products arena as well.
- read the release
- here's Reuters' take
- read the FDA clearance