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SPOTLIGHT ON: THE LEVA®PELVIC HEALTH SYSTEM, BY AXENA HEALTH
Axena Health, Inc. (“Axena”) is a women-led company relentlessly dedicated to women’s health and improving the lives of women experiencing bothersome bladder and/or bowel leakage. Axena’s flagship FDA-cleared product, the Leva® Pelvic Health System, offers an effective, first-line treatment for urinary incontinence (UI) also referred to as bladder leakage which is an underreported condition affecting 78 million women in the U.S. alone. In addition to UI, the Leva Pelvic Health System is also FDA-cleared for the treatment of chronic fecal incontinence and general pelvic floor muscle strengthening.
1) NIH Updated Prevalence of Urinary Incontinence in Women 2) NIH Urinary incontinence in women
UI can negatively impact a woman’s quality of life and can contribute to other potentially severe medical conditions. Despite its prevalence and adverse effects on women’s health, UI is often underreported by women and thus not addressed by many clinicians. Fortunately, groups such as ACOG (American College of Obstetricians and Gynecologists) and WPSI (Women’s Preventive Services Initiative) are increasingly recommending screening for pelvic floor disorders including UI. Early intervention has been shown to resolve or reduce symptoms, improve immediate and long-term condition-specific quality of life, and limit the need for more invasive and costly treatments.
About LEVA
The Leva Pelvic Health System offers a non-invasive, non-drug, non-surgical effective way for women to train and strengthen their pelvic floor muscles—at home (or from anywhere) in just five minutes a day for 12 weeks—to treat urinary and fecal incontinence.
- The small Levadevice is inserted vaginally and has motion sensors that communicate wirelessly with the Leva app on the user’s smartphone to offer precise guidance of pelvic floor muscle movement in real-time.
- The Levaapp is customized to each user’s needs and offers progress tracking and educational modules.
- Women are paired with a Coach from the Leva Women’s Center who help keep women motivated and accountable.
- Finally, the program enables active physician involvement, with monthly patient reports that show symptom improvement information. All of which support a women’s success.
Leva is available by prescription only, allowing physicians the opportunity to treat UI and FI on a broad scale and with continued involvement in patient success.
Published data from globally recognized medical centers support Leva’s efficacy.
Pivotal 8-week randomized controlled trial, published in ACOG’s Green Journal in April 2022 shows Leva users had about an 80% reduction in bladder leakage episodes by the end of 8 weeks and most Leva users experienced these symptom improvements as early as four weeks into treatment.
A follow up to the 8-week pivotal RCT at 18- and 24- months, published in the International Urogynecology Journal in January 2024 shows results achieved with an initial course of Leva treatment persisted for at least two years, making Leva an accessible first-line solution for women and a scalable solution for providers.
- Leva is effective for stress, mixed, and urgency UI (including overactive bladder).
- 78% of Leva users saw significant symptom relief comparable to supervised PFMT in Cochrane Reviews.
- 72% device-reported adherence at 4 weeks, which is impressive for a first line treatment option.
Learn More
For more information about the Leva Pelvic Health System please visit www.levacares.com or follow Leva on Facebook, TikTok, Instagram, and LinkedIn.
Important Safety Information for Leva Pelvic Health System
The Leva Pelvic Health System is intended for: (1) strengthening of pelvic floor muscles, (2) rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed, and mild to moderate urgency urinary incontinence (including overactive bladder) in women and (3) rehabilitation and training of weak pelvic floor muscles for the first-line treatment of chronic fecal incontinence (>3-month uncontrolled passage of feces) in women. Treatment with the Leva System is by prescription and is not for everyone. Please talk to your prescriber to see if Leva System is right for you.
Your prescriber should discuss all potential benefits and risks with you. Do not use Leva System while pregnant, or if you think you may be pregnant, unless authorized by your doctor.
For a complete summary of the risks and instructions for the Leva System, see its Instructions for Use available at www.levacares.com.
© 2024 Axena Health, Inc. Leva and Leva Pelvic Health System are registered trademarks of Axena Health. All rights reserved. All other trademarks are the property of their respective owners.
