AMA issues category III CPT code for placement of Voro Urologic Scaffold

The American Medical Association (AMA) has issued a category III Current Procedural Terminology (CPT) add-on code for placement of the Voro Urologic Scaffold when performed at the time of radical prostatectomy for patients with prostate cancer, Levee Medical announced in a news release.¹

The Voro Urologic Scaffold is an investigational device for managing stress urinary incontinence following prostatectomy. According to Levee Medical, the bioabsorbable device is “designed to support the bladder neck and preserve urethral length; two anatomical factors associated with earlier return to continence following prostate surgery.”

"The AMA's creation of Category III CPT code for the placement of the Voro Urologic Scaffold is an important step forward in validating our technology and paving the way for reimbursement," said Adam Irving, CEO of Levee Medical, in the news release.¹ "The new code, backed by leading medical societies that treat prostate cancer, underscores the need for improved options to prevent and manage stress urinary incontinence after radical prostatectomy."

Urologists can begin using the new CPT code starting on July 1, 2026. Category III CPT codes are temporary codes given to procedures using emerging technologies and services.

"Obtaining a unique Category III CPT code which describes the Voro procedure will allow CMS and private payers to track physician utilization with the future goal of expeditiously transitioning to a Category I CPT code," explained Jeffrey Dann, MD, past chairman of the American Urological Association Coding and Reimbursement Committee and former CPT Editorial Panel Advisor, in the news release.¹

The Voro Urologic Scaffold is currently under investigation in the pivotal phase 3 ARID II trial (NCT06873581), assessing the safety and effectiveness of the device in adult men undergoing radical prostatectomy. The first patient was enrolled in the study in April 2025 at the Mississippi Baptist Medical Center.²

In total, the single-blind, randomized controlled trial plans to enroll 266 adult patients with prostate cancer who are scheduled to undergo robotic-assisted radical prostatectomy. Participants will be enrolled through up to 30 clinical trial sites in the US.³ To be eligible for enrollment, patients must be 45 years or older and need to have Gleason grade group 4 or lower disease and a prostate size less than 80 grams.

Those included in the study will be randomly assigned to receive the Voro Urologic Scaffold during the prostatectomy procedure after prostate removal or to a control arm, which will not receive the device. Follow-up assessments will be conducted at 6 weeks, 6 months, 12 months, 18 months, and 24 months after the procedure.

The primary outcome measures for the study are the occurrence of adverse events and the number of patients achieving continence per a 1-hour provocative pad weight test at 6 weeks post-prostatectomy. The study will also assess quality of life and continence rates at 6- and 12-months following the procedure as secondary outcomes.

Primary completion of the study is expected in February 2027, with final completion projected for February 2028.

REFERENCES

1. American Medical Association grants Levee Medical Category III CPT code for placement of Voro Urologic Scaffold. News release. Levee Medical. October 14, 2025. Accessed October 14, 2025. https://www.prnewswire.com/news-releases/american-medical-association-grants-levee-medical-category-iii-cpt-code-for-placement-of-voro-urologic-scaffold-302582735.html

2. Levee Medical announces first patient enrolled in ARID II IDE pivotal trial. News release. Levee Medical. April 24, 2025. Accessed October 14, 2025. https://leveemedical.com/levee-medical-announces-first-patient-enrolled-in-arid-ii-ide-pivotal-trial/

3. Pivotal study of Voro Urologic Scaffold (ARID II). ClinicalTrials.gov. Last updated April 8, 2025. Accessed October 14, 2025. https://clinicaltrials.gov/study/NCT06873581