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Pelvital Announces FDA Clearance of Flyte™, In-Home Pelvic Floor Muscle Treatment for Stress Urinary Incontinence


Pelvital, a medical know-how firm targeted on ladies’s well being, introduced it has obtained U.S. Food and Drug Administration (FDA) clearance for Flyte, a first-of-its-kind, non-invasive, intravaginal home-use machine that’s supposed for strengthening of the pelvic ground muscle groups, which has been discovered to assist ladies with stress urinary incontinence.

This press launch options multimedia. View the complete launch right here: https://www.businesswire.com/news/home/20200820005151/en/

More than 15 million American women suffer from stress urinary incontinence. Flyte is a new, FDA-cleared, clinically proven treatment that women can use from the convenience of home. (Photo: Business Wire)

More than 15 million American ladies endure from stress urinary incontinence. Flyte is a brand new, FDA-cleared, clinically confirmed remedy that ladies can use from the comfort of dwelling. (Photo: Business Wire)

According to the National Association for Incontinence, stress urinary incontinence (SUI) impacts an estimated 16.6 million ladies within the United States. The situation typically happens as a result of pelvic ground muscle groups and tissues have been weakened, stopping the urethra from closing adequately to carry urine within the bladder. Pelvital’s Flyteis the one product to make use of an increasing space of remedy known as mechanotherapy (the remedy of illness by bodily or mechanical means) to deal with pelvic ground muscle weak spot, the first underlying reason for feminine SUI.

“Proven in physician-led clinical studies, Flyte leverages the natural healing capabilities of skeletal muscle to provide a time-efficient, effective therapy that essentially turbo charges Kegel exercises, the gold standard conservative treatment for SUI. Flyte amplifies the treatment impact of Kegels so women see results much sooner; days to weeks instead of months to years,” stated Dale Wahlstrom, Co-Founder and Chief Executive Officer of Pelvital.

“Many women are just coping with SUI. Women with mild, moderate or severe SUI who want to avoid surgery, or a lengthy regimen of Kegel exercises now have a new option to treat their bladder leaks,” stated Carrie Vollmer, Vice President of Marketing. “Flyte is an easy-to-use, 5-minute-per-day treatment that is backed by strong clinical evidence.”

Flyte was initially developed by physicians from the Arctic University of Norway and different specialists in gynecology, muscle rehabilitation and urinary incontinence therapies. Two medical trials studied the protection and effectiveness of Flyte in Norway and the United States. Between the 2 research, greater than 200 sufferers have been handled utilizing Flyte; most sufferers have been dry or close to dry after 2 – 12 weeks of remedy.

Flyte shall be commercially out there to shoppers within the U.S. starting in August, 2020. For further details about Flyte, please go to www.FlyteTherapy.com.

About Pelvital

Founded in 2016, Pelvital is a privately held medical know-how firm targeted on ladies’s well being. Pelvital’s imaginative and prescient is to considerably enhance the lives of people that endure from pelvic ground problems by novel, easy-to-use merchandise backed by sturdy medical proof. The firm is targeted on increasing conservative remedy choices to encourage shoppers to deal with circumstances fairly than deal with signs.

Their first product, Flyte, is an easy, efficient in-home remedy for incontinence, designed to deal with weakened pelvic ground muscle groups to cut back bladder leaks and restore continence. For extra data go to pelvital.com.

Contact: Carrie Vollmer
[email protected]

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