WebNov 8, 2024 · Optilume was approved by the FDA in December 2024 for the treatment of men with urethral strictures. The AMA has issued a new Category 1 CPT Code (5X000) that facilitates the reimbursement of the Optilume drug-coated balloon catheter system for the treatment of men with urethral strictures. 1 WebOct 14, 2024 · Oct 14, 2024 Jason M. Broderick Interim 1-year results from the pivotal ROBUST III trial showed that the novel Optilume urethral drug-coated balloon improved …
Optilume for anterior urethral strictures - National Institute for ...
WebOptilume® is the cost-effective alternative³ to recurrent endoscopic management, breaking the cycle of recurrent urethral stricture disease. 4. ... Urethroplasty Urethroplasty involves surgical removal of the stricture and reconstruction of the urethra by performing an invasive, open surgical procedure. ... WebThe clinical guideline on male urethral stricture provides a clinical framework for the diagnosis of urethral stricture and includes discussion of diagnosis and initial management, urethroplasty, reconstruction, contracture, stenosis, special circumstances, and post-operative follow-up care. Unabridged version of this Guideline [pdf] inconsistency\\u0027s c3
FDA Approves Optilume® Urethral Drug Coated Balloon, a …
WebDec 15, 2024 · Urotronic’s Optilume urethral drug coated balloon has been approved for use in the US market and will challenge the current standard-of-care endoscopic treatments for male urethral strictures. On December 13 2024, the US FDA approved the Optilume balloon for use in male urethral strictures. This follows the Optilume’s approval in the EU ... WebFeb 2, 2024 · The Optilume drug-coated balloon catheter system was approved in the EU in September 2024 for the treatment of patients with urethral stricture. The first European patient has been successfully treated for urethral stricture with the Optilume drug-coated balloon catheter system, according to Laborie Medical Technologies. 1 WebJan 5, 2024 · Optilume may serve as an important alternative for men with recurrent strictures that want to avoid or delay urethroplasty.” 2 Urethral stricture affects men with an increasing incidence from about 1 in every 10,000 at 25 years old to about 1 in every 1,000 men at 65 or older. 3 inconsistency\\u0027s c7