BlueWind Medical Wins Favorable Reimbursement for Revi System

The Centers for Medicare & Medicaid Services (CMS) has finalized a 40% reimbursement rate increase next year for BlueWind Medical Ltd.’s Revi System.

For CY2025, CMS has set the national unadjusted Ambulatory Surgical Center (ASC) payment rate for Category III CPT code 0817T, which includes the Revi System, at $19,839—a 40% increase compared with the CY2024 rate. For the Hospital Outpatient setting, the CY2025 payment increased by 3% to $21,444. These adjustments highlight CMS’s recognition of the Revi System’s clinical benefits as a minimally invasive, effective solution for urge urinary incontinence (UUI), according to BlueWind Medical.

“The CMS decision to increase the reimbursement rate for the Revi System in the ASC setting reflects the growing recognition of iTNM as an effective, minimally invasive therapy for urgency urinary incontinence,” BlueWind Medical Chief Financial Officer/General Manager Steve Armstrong said. “This update underscores the proven durability, safety, and patient satisfaction research behind the Revi System as an important and innovative approach to treat this distressing condition.”

The Revi System is the first and only U.S. Food and Drug Administration (FDA)-cleared implantable Tibial Neuromodulation (iTNM) device activated by an external wireless wearable for patients with UUI, enabling patients to initiate therapy at their convenience. This patient-centric approach, paired with provider flexibility in treatment planning, delivers tailored UUI relief by stimulating the posterior tibial nerve.

As the first iTNM device labeled for use without requiring prior failure of more conservative therapies, Revi aligns with newly updated 2024 guidelines from the American Urological Association and the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU). These guidelines recommend early consideration of minimally invasive treatments for UUI and emphasize shared decision-making in overactive bladder (OAB) and UUI management. Revi’s positioning enables it to be offered early in the continuum of care, providing patients and physicians with a minimally invasive option.

Recent clinical data supports Revi’s durable efficacy, safety, and patient satisfaction for UUI treatment. Two-year findings from BlueWind Medical’s pivotal OASIS Study were presented at the American Urogynecologic Society (AUGS) Pelvic Floor Disorders (PFD) Week and the International Continence Society (ICS). Additional research from the company showed iTNM as an effective alternative to Sacral Neuromodulation (SNM) for OAB and UUI.

BlueWind Medical develops innovative, patient-centric medical technology for disease treatment. The Revi System is the first and only implantable tibial neuromodulation device activated by a battery-operated external wearable to receive FDA marketing authorization for patients with UUI. Revi is the only neuromodulation therapy on the market that allows physicians to use their discretion to determine whether the patient should fail or not tolerate more conservative treatments before using the Revi System rather than mandating “step-therapy.”