BlueWind Medical, developer of the Revi® System for urgency urinary incontinence (UUI), today announced that the American Medical Association (AMA) CPT® Editorial Panel has approved a new Category I CPT code for subfascial implantation of a tibial neuromodulation device. The new code takes effect January 1, 2028.
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credit: BlueWind Medical Revi System
Revi has demonstrated durable results with efficacy of 79% at three years and 95% patient satisfaction. Designed for a 15-year implant life, the miniature device is placed near the ankle in an outpatient procedure under local anesthesia. Patients receive personalized therapy at home that is powered using a lightweight external wearable transmitter.
Revi offers patients the ability to control when to activate their therapy and the amount of therapy they desire along with the added benefit of not requiring frequent device replacement due to short battery life.
The new Category I code recognizes the distinct physician work and procedural complexity involved in subfascial implantation, differentiating it from subcutaneous placement of a tibial neuromodulation device. Revi’s subfascial placement positions the implant in close proximity to the tibial nerve. Due to the elegant nature of the implant procedure, Revi can safely be implanted in an Ambulatory Surgery Center or hospital outpatient department.
Separate codes for subfascial and subcutaneous implantation will also allow payers to distinguish the procedures in claims data, supporting long-term tracking and comparison of outcomes associated with each approach when linked with clinical data.
“This coding milestone and the differentiation between subfascial and subcutaneous procedures in the coding structure reflects the AMA’s recognition of the distinct work physicians perform for subfascial placement. Subfascial placement, which places the device closer to the tibial nerve, along with Revi’s durable clinical outcomes, are attributes that distinguish Revi for patients,” said Kerry Nelson, Chief Executive Officer of BlueWind Medical. “With 79% efficacy at three years, 95% patient satisfaction and a device designed for a 15-year implant life, Revi offers a compelling long-term treatment option. We are grateful to the physicians and our professional society partners whose expertise, advocacy and support helped make this milestone possible.”
Physician Input Is the Next Step
The next step in the process is a physician survey conducted through the AMA/Specialty Society RVS Update Committee (RUC) process. Participating urologists will have an opportunity to provide input on the time, intensity and complexity of the physician work required for subfascial implantation. Those responses will inform recommendations to the Centers for Medicare & Medicaid Services regarding physician payment valuation.
“Urologists have an important opportunity to help ensure that the work involved in this procedure is accurately represented,” added Dr. Roger Dmochowski, BlueWind Medical’s Chief Medical Officer. “We encourage physicians selected to participate to complete the survey and share their experience with subfascial placement.”
The Category I code establishes a distinct reporting pathway for the procedure. Payment rates and payer coverage policies will be determined separately.
About the Revi System
The Revi® System is an FDA-approved tibial neuromodulation treatment for urgency urinary incontinence. Its miniature implant is placed near the ankle and powered by a lightweight external wearable that patients use to receive personalized therapy at home. Designed for a 15-year implant life, Revi avoids the need for implanted battery replacements and repeated office visits for routine treatment.
About BlueWind Medical
BlueWind Medical is a medical device company focused on advancing treatment for urgency urinary incontinence. Through the Revi System, the company aims to provide durable symptom relief with a simple implantation procedure and personalized therapy that fits into patients’ daily lives.
For more information, visit https://bluewindmedical.com
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