The US Food and Drug Administration (FDA) has granted 510(k) clearance for Renovia’s next-generation leva Pelvic Digital Therapeutic device.
The leva Digital Therapeutic device helps to make the pelvic floor muscles stronger, treating urinary incontinence (UI) condition in women who could be suffering in varying intensities.
By leveraging Renovia’s patented movement-based sensor and app technology, the next-generation leva Digital Therapeutic provides feedback in real-time to women as they carry out pelvic floor muscle exercises.
The next-generation leva Digital Therapeutic features the same dynamics of action and sensor technology found in the current-generation leva Digital Therapeutic device that is claimed to have shown improvement in pelvic floor muscle (PFM) performance measures, patient-reported UI symptom severity and condition-specific quality of life.
Renovia co-founder chairman and chief executive officer Marc Beer said: “We are thrilled to receive FDA clearance for the next-generation leva Digital Therapeutic.
“Over the past two years, the Renovia team has taken the peer-reviewed mechanism of action of the existing leva device and completely reimagined it in a patient-centric form factor. The next-generation leva combines our clinically-established and patented technology with a new discreet form factor and a completely redesigned app interface.”
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Recently, the company completed a multi-centre, pilot randomised controlled trial (RCT) of the device. This trial saw the participation of 60 subjects, with the control group performing traditional Kegel exercises.
According to the company, the results of the study demonstrated better results among leva users.
Renovia chief medical officer Samantha Pulliam said: “Renovia is focused on improving the standard of care for female pelvic floor disorders through innovative products supported by world-class clinical evidence.
“FDA clearance of the next generation of the leva Digital Therapeutic is one of many milestones that we believe will allow us to improve care for the millions of women who experience UI and other pelvic floor disorders.”
In the US, nearly 20 million women are estimated to be suffering from urinary incontinence that can lead to potentially severe medical problems.
With the approval, the company expects to release the next-generation leva Digital Therapeutic for sale between March and June next year.