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Pelvital Launches Next-Generation FDA-Cleared Flyte® System, Treating All Severities of Stress Urinary Incontinence


News provided by

Pelvital

Dec 11, 2024, 10:58 ET

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Flyte by Pelvital
Flyte by Pelvital

The new Flyte App and Provider Portal offer enhanced tracking and personalization for women suffering from mild to severe SUI, improving care outcomes and provider-patient collaboration

EAGAN, Minn., Dec. 11, 2024 /PRNewswire-PRWeb/ -- Pelvital, the women's health MedTech company transforming the conservative standard of care for urinary incontinence, proudly announces the launch of the next generation of its Flyte® System, offering patients and healthcare providers additional tools to track progress and optimize treatment outcomes.

Flyte, an FDA-cleared, non-invasive, at-home solution designed to strengthen pelvic floor muscles to treat women suffering from stress urinary incontinence (SUI), is now cleared to treat women across all levels of SUI severity, including mild, moderate, and severe cases.

"Flyte has already transformed the lives of thousands of women with stress urinary incontinence, providing an accessible, effective alternative to surgery or other invasive procedures," says Lydia Zeller, CEO and President of Pelvital. "We are thrilled to introduce new features that make this next generation even more user-friendly while maintaining the proven clinical outcomes for which Flyte is renowned."

The Flyte App serves as an additional HIPAA-compliant interface, guiding users through their treatment sessions and providing real-time monitoring of pelvic muscle control. Additionally, the application collects treatment and patient-reported outcomes data, allowing patients to easily track multiple aspects of treatment progress. While the app is not required for use of the device, patients can benefit from a more personalized and interactive experience.

The Flyte Provider Portal is a HIPAA-compliant web portal that, with patient consent, allows healthcare providers to view detailed device and adherence data, monitor patient progress, and track impact on patient health. This feature enhances the provider-patient connection, allowing for more informed care. Like the app, the portal is optional and is not required for the system's operation.

Flyte's unique mechanotherapy approach, a well-established treatment modality shown in the literature to stimulate tissue regeneration and the creation of neuromuscular memory, has demonstrated outcomes comparable to surgical outcomes in two published peer-reviewed clinical trials.

About Pelvital

Pelvital USA, Inc. is a women's health medical device company empowering women and clinicians to restore pelvic health with effective, convenient products backed by strong clinical evidence. Their first product, Flyte®, is an FDA-cleared novel in-home treatment for stress urinary incontinence and weakened pelvic floor muscles. Flyte is the first and only in-home product to deliver the therapeutic treatment modality of mechanotherapy to the pelvic floor. Mechanotherapy is a well-established treatment modality that stimulates tissue regeneration and the creation of neuromuscular memory. Learn more at flytetherapy.com.

Media Contact

Christine Joyce, Pelvital, 1 2015720089, [email protected], https://flytetherapy.com/ 

SOURCE Pelvital

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