Axena Health has announced that its Leva Pelvic Health System received a new Healthcare Common Procedure Coding System (HCPCS) Level II code from the Centers for Medicare & Medicaid Services (CMS) in the US.

The new code is effective from 1 April 2024. It aims to streamline the process for clinicians, distributors, payers, and patients to access the system, a clinically validated, non-invasive treatment for urinary incontinence (UI) and faecal incontinence (FI) in women.

Axena Health CEO Eileen Maus said: “The new code removes barriers that have kept treatment out of reach by defining a clear path as a medical benefit through patients’ durable medical equipment coverage.

“The Leva System’s HCPCS code, along with its previously established pharmacy code, make either channel an option to increase access through insurance.”

The Leva Pelvic Health System is a prescription medical device that combines an intra-vaginal probe with integrated software.

Featuring patented, motion-based technology, it allows women to correctly treat UI and FI through pelvic floor muscle training (PFMT), known as Kegels, at home.

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Axena Health chief medical officer Samantha Pulliam said: “PFMT, commonly practised via Kegels, is a first-line treatment but data show achieving effective, consistent practice is challenging.

“The Leva System makes PFMT accessible by guiding women through their treatment, effectively, enabling supervised PFMT. And this new code is a huge step towards making the Leva System available to all women who need symptom relief.”

A study published earlier this year demonstrated that the Leva System provided superior UI symptom improvement compared to typical unsupervised home PFMT.

The accelerometer-based technology of the system offers real-time visualisation and guidance, ensuring that PFMT is performed correctly.

In 2021, the US Food and Drug Administration (FDA) granted breakthrough device designation to the Leva System for the treatment of chronic FI.