Devices for Treatment of Benign Prostatic Hyperplasia, Urethral Stricture, and Urethral Stenosis
Effective January 1, 2027, the Optilume Urethral Drug Coated Balloon may be considered medically necessary for recurrent anterior (bulbar) urethral stricture when the stricture is located in the anterior (bulbar) urethra, is 3 cm or less in length, and has failed prior endoscopic treatment such as direct visual internal urethrotomy or dilation. The Optilume Urethral Drug Coated Balloon is investigational when those criteria are not met, including penile urethral stricture, first-time treatment, and repeated use of the device. The temporarily implanted nitinol device (iTind), the Optilume BPH Catheter System, and the prostatic urethral scaffold (Zenflow Spring) are investigational for all indications.