Correction and Update: Axena Health Secures Two More Favorable Insurance Coverage Approvals for Leva

Axena Health Secures Expanded Insurance Coverage for Leva Pelvic Health System

Axena Health, Inc. (Axena Health) has achieved a significant milestone in expanding insurance coverage for its Leva® Pelvic Health System. Two major health plans in Pennsylvania and North Dakota have now included the Leva system as a covered benefit for their members dealing with urinary incontinence, effective from April 1, 2024.

The Leva Pelvic Health System (HCPCS Level II code, S9002) consists of a small, flexible intra-vaginal probe embedded with multiple accelerometer motion sensors. This device communicates with patients via integrated software to guide pelvic floor muscle treatment. Urinary incontinence affects 62% of adult women in the U.S. and can severely impact quality of life without treatment. The Leva System is FDA-cleared to treat stress, mixed, and mild-to-moderate urgency urinary incontinence, as well as chronic fecal incontinence in women.

Dr. Vincent Lucente, MD, MBA, FACOG, URPS, Physician Leader for Urogynecology at The Institute for Female Pelvic Medicine and Reconstructive Surgery, emphasized the challenges in pelvic floor muscle treatment and praised Leva’s efficacy and convenience. The system allows for at-home use, requiring just five minutes per day over eight to twelve weeks.

Samantha J. Pulliam, M.D., Chief Medical Officer for Axena Health, highlighted the significance of insurance coverage in expanding access to effective treatments, especially in underserved areas lacking pelvic floor care specialists. Interim CEO Jim O’Connor expressed optimism about the impact of these coverage decisions, emphasizing the Leva System’s ability to provide long-lasting symptom improvement.

The Leva® Pelvic Health System represents a non-invasive, medication-free approach for women seeking to strengthen pelvic floor muscles. It combines advanced technology with physician involvement to optimize treatment outcomes. Axena Health continues to support its efficacy through clinical trials and real-world evidence, aiming to improve the quality of life for women nationwide.

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