Optilume® urethral drug coated balloon
WebDec 13, 2024 · The FDA has approved the Optilume drug-coated balloon catheter system for the treatment of men with urethral strictures. 1 The approval was based on data from the ROBUST I and ROBUST 3 clinical trials. The ROBUST I pilot study (NCT03014726) enrolled and treated 53 patients with recurrent bulbar strictures ≤2 cm who had received 1 to 4 … WebDec 13, 2024 · MINNEAPOLIS, Dec. 13, 2024 /PRNewswire/ -- Urotronic, Inc., a Minnesota based medical device company, today announced that the U.S. Food and Drug Administration (FDA) has approved the Optilume® Urethral Drug Coated Balloon for use in male urethral strictures. Optilume was granted CE mark approval for use in urethral …
Optilume® urethral drug coated balloon
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WebThe Optilume (Urotronic, Plymouth, MN, USA) drug-coated balloon, Figure 1, is a minimally invasive urethral stricture treatment developed in response to demand for improved … WebDec 13, 2024 · The Optilume® drug-coated balloon technology provides a low cost, minimally invasive treatment option for men suffering from urinary tract conditions like urethral strictures and benign prostatic ...
WebPurpose: The Optilume® drug-coated balloon (DCB) is a urethral dilation balloon with a paclitaxel coating that combines mechanical dilation for immediate symptomatic relief … WebNov 7, 2024 · Optilume’s paclitaxel-coated balloon technology combines mechanical dilation for immediate symptomatic relief with local drug delivery to maintain urethral patency. The technology was developed in response to patient and physician dissatisfaction with current endoscopic solutions for urethral strictures.
WebThe Optilume drug-coated balloon represents a step forward in the endoscopic management of urethral strictures. The drug-coated balloon may offer an intermediate step prior to repeated dilations, urethrostomies, or urethroplasty. WebThis study investigates the safety and efficacy of the Optilume™ paclitaxel-coated balloon for the treatment of recurrent strictures. Methods: Men with recurrent bulbar strictures ≤2 cm with 1-4 prior endoscopic treatments were treated with the Optilume™ drug-coated balloon. Patients were evaluated within 14 days, three, six, 12, and 24 ...
WebMar 1, 2024 · Laborie’s Optilume® Urethral Drug Coated Balloon Technology Wins Approval from Australia TGA Optilume ® combines balloon dilation of the urethral stricture with the delivery of an anti-proliferative drug to prevent recurrence of the blockage.
WebApr 10, 2024 · PDF On Apr 10, 2024, Laura Kelly and others published Economic evaluation of Optilume, a drug‐coated balloon for recurrent anterior male urethral stricture Find, … philosophy and apologeticsWebIntroduction: We aimed to investigate the safety and preliminary efficacy of the Optilume™ paclitaxel-coated balloon for the treatment of recurrent urethral stricture. Methods: Men with bulbar urethral strictures ≤2 cm with 1-4 prior endoscopic treatments were enrolled at four study sites after ethics committee approvals. All subjects were treated with … philosophy and autismWebDec 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. philosophy and approach of paleo dietWebApr 8, 2024 · The Optilume ® BPH Catheter System (Urotronic Inc., Plymouth, Minnesota, USA) is the first prostatic drug-coated balloon dilation system for the treatment of … t shirt fille adoWebThe Optilume drug-coated balloon is an exciting innovation in urethral stricture treatment—giving patients and physicians an effective solution that can deliver Laborie Medical owns the global commercialization … t shirt fille originauxWebJan 5, 2024 · The technology. Optilume (Urotronic) is a drug-coated balloon indicated for treating anterior urethral strictures. The technology combines balloon dilation, to expand or widen the strictured area, with delivering an anti-proliferative drug (paclitaxel) to reduce stricture recurrence. Optilume is inserted under direct endoscopic vision (with or ... t shirt fille la redouteWebMar 17, 2024 · The device uses a drug coated balloon to dilate the urethra at the site of the stricture. The balloon is coated on its outer surface with paclitaxel, which is then … t shirt fila garcon