AMA issues Category I CPT codes for implantable tibial neuromodulation in UUI

The American Medical Association (AMA) Current Procedural Terminology (CPT) Editorial Panel has issued new Category I CPT codes for implantable tibial neuromodulation for urgency urinary incontinence (UUI). The codes take effect in January 2028 and separate subfascial implantation from subcutaneous implantation.

Separate announcements came from BlueWind Medical, maker of the Revi System, and from Medtronic, maker of the Altaviva device.^1,2 The codes replace the Category III tracking codes now used for these procedures.

According toBlueWind Medical, the new Category I code for subfascial implantation "recognizes the distinct physician work and procedural complexity involved in subfascial implantation." The company added that separate codes will let payers tell the 2 approaches apart in claims data, “supporting long-term tracking and comparison of outcomes associated with each approach when linked with clinical data.”¹

The devices and their evidence

Valencia Technologies' eCoin was the first implantable tibial device in this group. The FDA approved it in March 2022 for UUI in patients who did not respond to conservative treatment. In its pivotal study (NCT03556891), 78% of the 72 patients who reached 96 weeks had at least a 50% reduction in UUI episodes.³

The FDA authorized the Revi System through the De Novo pathway in 2023, and later versions were cleared by 510(k). The Revi implant is placed under the fascia near the tibial nerve during an outpatient procedure under local anesthesia. The device powered by an external wearable that the patient controls.

The pivotal OASIS study (NCT03596671) implanted the device in 151 women.⁴ Of 119 women who agreed to extended follow-up, 90 completed the 36-month visit. Among those 90, 79% were responders, meaning at least a 50% reduction in UUI episodes on a 3-day voiding diary. The 6-month responder rate was 78%. Satisfaction with therapy was 95%. The study reported no serious adverse events related to the device or the procedure through 3 years.

The FDA approved Medtronic's Altaviva through premarket approval in September 2025 for UUI in patients who failed or could not tolerate more conservative treatments. The device is placed under the skin near the ankle. Medtronic says implantation needs no imaging, uses only local anesthesia, and allows activation the same day.

In the single-arm pivotal TITAN 2 study (NCT05226286), 126 patients received the implant; 95% were women, mean age was 63 years, and mean BMI was 35 kg/m².⁵ The study met its primary end point: 59% of patients (95% CI, 49 to 67) had at least a 50% reduction in daily UUI episodes at 6 months, and 61% did at 12 months. Adverse device effects occurred in 20% of patients through 12 months. One was serious, and it resolved.

Next steps

The AMA/Specialty Society RVS Update Committee (RUC) is conducting a physician survey on the time, intensity, and complexity of the work for subfascial implantation. The results will shape recommendations to the Centers for Medicare & Medicaid Services on payment.

"Urologists have an important opportunity to help ensure that the work involved in this procedure is accurately represented," explained Roger Dmochowski, MD, MMHC, FACS, BlueWind Medical's Chief Medical Officer, in the news release from the company.¹ "We encourage physicians selected to participate to complete the survey and share their experience with subfascial placement."¹

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REFERENCES
1. BlueWind Medical announces Category I CPT code for subfascial tibial neuromodulation. News release. BlueWind Medical. October 2, 2026. Accessed October 2, 2026. https://www.businesswire.com/news/home/20261002313105/en/BlueWind-Medical-Announces-Category-I-CPT-Code-for-Subfascial-Tibial-Neuromodulation

2. Medtronic receives Category I CPT® code approvals for Altaviva™ and Symplicity Spyral™ Systems. News release. Medtronic plc. October 1, 2026. Accessed October 2, 2026. https://www.prnewswire.com/news-releases/medtronic-receives-category-i-cpt-code-approvals-for-altaviva-and-symplicity-spyral-systems-302896491.html

3. Lucente V, Giusto L, MacDiarmid S. Two-year Pivotal Study Analysis of the Safety and Efficacy of Implantable Tibial Nerve Stimulation With eCoin® for Urgency Urinary Incontinence. Urology. 2024:194:17-23. doi:10.1016/j.urology.2024.07.046

4. Amundsen CL, Sutherland SE, Heesakkers JPFA, et al. Three-Year Efficacy and Safety of Revi Implantable Tibial Neuromodulation from the Pivotal OASIS Study. J Urol. 2026;216(2):219-229. doi:10.1097/JU.0000000000005062

5. Lee U, Xavier K, Carey J, et al. Implantable Tibial Neuromodulation Therapy Improves Symptoms of Urge Urinary Incontinence From the TITAN 2 Pivotal Study. J Urol. 2026;215(6):702-712. doi:10.1097/JU.0000000000004958