The prevalence of BPH and lower urinary tract issues rises markedly with increased age. The Optilume drug coated balloon technology creates a paradigm change from the methods currently used by urologists to treat urethral stricture disease. 3. Emnerne vil blive tilmeldt og behandlet med Optilume BPH Prostatic DCB Dilatation Catheter System p op til 8 kliniske steder. Optilume works by preventing new scar tissue growth that often returns after dilations or DVIU. The device uses a drug coated balloon to dilate the urethra at the site of the stricture. The Optilume Urethral Drug Coated Balloon (DCB) is a urethral dilation balloon with a proprietary paclitaxel coating that combines mechanical dilation of the stricture for immediate symptomatic relief with local drug delivery to maintain urethral patency. Last year, the US-based medical equipment manufacturer has secured the CE mark approval for its Optilume for the same indication. It is novel compared to existing endoscopic standard of care as it incorporates urethral dilation, to widen the strictured area, with an anti-proliferative drug (Paclitaxel) which is delivered circumferentially along the strictured inner urethral wall to prevent the . Methods: Men with recurrent bulbar strictures 2 cm with 1-4 prior endoscopic treatments were treated with the Optilume drug-coated balloon. FDA approves Optilume drug-coated balloon catheter for urethral strictures December 13, 2021 Jason M. Broderick The FDA has approved the Optilume drug-coated balloon catheter system for the treatment of men with urethral strictures. 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. The distal end of the catheter has an inflatable balloon coated with a proprietary coating containing the drug paclitaxel that facilitates the drug's transfer to the urethral wall upon inflation. The Optilume BPH Catheter System (Urotronic Inc., Plymouth, Minnesota, USA) is the first prostatic drug-coated balloon dilation system for the treatment of obstructive BPH. December 13, 2021 By Danielle Kirsh Urotronic today announced that it received FDA approval for its Optilume urethral drug-coated balloon for male urethral strictures. The Optilume Urethral Drug Coated Balloon (DCB) uses a drug-coated balloon attached to the end of a urethral catheter to expand the urethra, that may be abnormally narrowed (. 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 hyperplasia (BPH). Erhalten Sie einen Einblick in die Anwendererfahrungen von Optilume DCB und besuchen Sie unser Satellitensymposium an Stand S.101 in der Industrieausstellung. The subjects may choose to be followed-up annually for 5 years or until study close, whichever comes first. Balloon dilation followed to 30Fr for 10 minutes after which a 14Fr transurethral catheter was placed for two days. The Optilume drug-coated balloon technology provides a low cost, minimally-invasive treatment option for men suffering from urinary track conditions like benign prostatic hyperplasia (BPH . 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 . Here, we report the 3-year results of the ROBUST I trial, which evaluated the safety and efficacy of the Optilume drug coated balloon (DCB) in men with recurrent urethral strictures. The subjects will be enrolled and treated with the Optilume BPH Prostatic DCB Dilation Catheter System at up to 8 clinical sites. The Optilume drug-coated balloon technology provides a low cost, minimally invasive treatment option for men suffering from urinary track conditions like benign prostatic hyperplasia (BPH) and urethral stricture. Truckee, CA (UroToday.com) Doctors are beginning a clinical study of a new medical solution that could dramatically change the way urethral strictures are treated today for millions of men around the world. The Optilume drug-coated balloon (DCB) is a urethral dilation balloon with a paclitaxel coating that combines mechanical dilation for immediate symptomatic relief with local drug delivery to maintain urethral patency. Congratulations to Dr. Craig Hunter and the staff at Mountain View Hospital for performing the first #Optilume procedure in Las Vegas! 8-Minute procedural guide video for the Optilume urethral drug coated balloon for urethral stricture treatment.For more information on this product or to set. This study investigates the safety and efficacy of the Optilume paclitaxel-coated balloon for the treatment of recurrent strictures. Patrocinadores: Patrocinador Principal: Urotronic Inc. Fonte: Urotronic Inc. Sumrio breve: O estudo ROBUST IV foi desenvolvido para "perceber melhor os resultados do mundo real" para homens dilatao uretral usando o Optilume Drug Coated Balloon (DCB) para tratamento de estenose uretral. Excited to speak at International Continence Society (ICS) 2022 Product Theatre. Optilume was granted CE mark approval for use in urethral strictures in 2020. Interventions Device: Optilume BPH Prostatic DCB Dilation Catheter Congratulations to Dr. Craig Hunter and the staff at Mountain View Hospital for performing the first #Optilume procedure in Las Vegas! J Urol. 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 hyperplasia (BPH). Methods: Men with recurrent bulbar strictures 2 cm with 1-4 prior endoscopic treatments were treated with the Optilume drug-coated balloon. Optilume drug-coated balloon is a novel treatment for anterior urethral strictures in men. With both products, the Optilume drug coated balloon is used to exert gentle radial force to dilate the urethra to overcome the narrowed obstruction present before treatment providing greater flow of urine exiting the body. BPH affects 70% of men 60-69 years of age . MP56-06 The Optilume Drug Coated Balloon for Recurrent Anterior Urethral Strictures: ROBUST I Clinical Study 3-year follow up, N = 43. Thank . Urotronic has received the US Food and Drug Administration (FDA) approval for its Optilume Urethral Drug Coated Balloon to support the treatment of male urethral strictures. The Optilume Drug Coated Balloon (DCB) procedure is an innovative treatment for urethral stricture in adult males >18 years old. Purpose: The Optilume drug-coated balloon (DCB) is a urethral dilation balloon with a paclitaxel coating that combines mechanical dilation for immediate symptomatic relief with local drug delivery to maintain urethral patency. Patients were evaluated within 14 days, three, six . The US Food and Drug Administration (FDA) has approved the Urotronic Optilume Urethral Drug Coated Balloon to treat urethral strictures in males. Optilume Drug-Coated Balloon for Urethral Strictures We're excited to add a new treatment to our range of highly effective, minimally-invasive specialty procedures - Optilume. It has been effectively used in millions of patients worldwide since 1992, in various applications. Thank . Efficacy outcomes included symptomatic assessments, erectile function measured using the International Index of Erectile . The objective of the study is to evaluate the safety and efficacy of the Optilume BPH Prostatic Drug Coated Balloon Dilation Catheter System in the treatment . Epub ahead of print. The prevalence of BPH and lower urinary tract issues rises markedly with increased age. .i am waiting for a new treatment which has been introduced by urotronic .first patient got treatment in canada by the optilume drug coated balloon catheter of urotronic.actually urotronic has introduced this dcb to make urethrotomy successfull bcoz this drug coated . The Optilume drug-coated balloon (DCB), developed by Urotronic . The procedure is done under flexible cystoscopy guidance and involves a combination of balloon dilatation of the urethral stricture and treating the dilated area with paclitaxel, a microtubule inhibitor. Here, we report the 3-year results of the ROBUST I trial, which evaluated the safety and efficacy of the Optilume drug coated balloon (DCB) in men with recurrent urethral strictures. Methods: Adult men with recurrent bulbar urethral strictures 2 cm in length and 1-4 prior endoscopic interventions were treated with the Optilume DCB. The Optilume Drug Coated Balloon (DCB) is a urethral dilation balloon with a paclitaxel coating that combines mechanical dilation for immediate symptomatic relief with local drug delivery to maintain urethral patency. The primary safety endpoint was the rate of treatment-related serious complications at 90 days post-procedure. The prevalence of BPH and lower urinary tract issues rises markedly with increased age. The Optilume drug-coated balloon represents a step forward in the endoscopic management of urethral strictures. After placing a transurethral guidewire, the 3cm Optilume DCB was positioned to overlap the stricture on both ends ( Fig. 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. Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters Sponsors: Lead Sponsor: Urotronic Inc. #ForDignityForLife #Urology #Urogynecology #Optilume https://hubs.li/Q01l-4Vc0 An exciting, minimally invasive urethral stricture treatment, the Optilume drug-coated balloon was developed in response to severe patient and physician dissatisfaction with current stricture solutions. According to the company, its Optilume . The drug-coated balloon may offer an intermediate step prior to repeated dilations, urethrostomies, or urethroplasty. The distal end of the catheter has an inflatable balloon coated with a proprietary coating containing the drug paclitaxel that facilitates the drug's transfer to the urethral wall upon inflation. https://lnkd.in/e-9azZ7W #LABORIE #OPTILUME #urology #LABORIE #OPTILUME #urology - Optilume is an effective alternative to traditional endoscopic stricture treatments for male urethral strictures, offering minimally invasive, . Approval of the Optilume Urethral Drug Coated Balloon. Optilume | Break the stricture cycle Urotronic is focused on developing Drug Coated Balloons which we believe are the future of interventional urology. Methods: Men with recurrent bulbar strictures 2 cm with 1-4 prior endoscopic treatments were treated with the Optilume drug-coated balloon. The Optilume technology combines drug-coated balloon dilation, to expand or widen the strictured area, with delivering an anti-proliferative drug (paclitaxel) to reduce stricture recurrence and facilitate circumferential drug absorption. Methods: Adult men with recurrent bulbar urethral strictures 2 cm in length and 1- 4 prior endoscopic interventions were treated with the Optilume DCB. The ROBUST III study is a randomized, single-blind trial evaluating the safety and efficacy of the Optilume DCB against endoscopic management of recurrent anterior . For patients who have failed prior endoscopic treatment, today there is Optilume a breakthrough urethral drug-coated balloon treatment that dilates the ur. Urotronic offers new hope for men suffering from Urethral strictures. Territory Manager Uro Pathway West - Optilume Urethral Drug-Coated Balloon, Eclipse non-surgical Fecal Incontinence Solution, Urgent PC, Macroplastique, Portascan 3D Bladder Scanner . The balloon is coated on its outer surface with paclitaxel, which is then transferred to the urethral wall and is theorised to prevent the stricture from recurring. The Optilume drug-coated balloon technology provides a low cost, minimally-invasive treatment option for men suffering from urinary track conditions like benign prostatic hyperplasia (BPH), urethral and ureteral strictures, and bladder neck contractures (BNC). The Food and Drug Administration (FDA) has approved the Optilume Urethral Drug Coated Balloon (DCB) to treat patients with obstructive urinary symptoms associated with anterior urethral. MINNEAPOLIS, Dec. 13, 2021 /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. The post-treatment follow-up visit can be up to 5 years. The prevalence of BPH and lower urinary tract issues rises markedly with increased age. Det opflgningsbesg efter behandling kan vare op til 5 r. It is designed to be used in adult males for urethral strictures of less than or equal to 3 cm in length. doi: 10.1097/JU.0000000000002346. J Urol 2021;206(3S . Formlet med undersgelsen er at evaluere sikkerheden og effektiviteten af Optilume BPH Prostatic Drug Coated Balloon Dilatation Catheter System til . Change in IPSS score at 3-month post-procedure follow-up; 2). Why opt for Optilume? Optilume drug-coated balloon represents a step forward in the endoscopic management of urethral strictures. Study primarily outcomes are measured by 1). The system combines mechanical dilation to achieve commissurotomy of the anterior prostatic urethra to open the urethral lumen, with the delivery of the drug paclitaxel . "Optilume exhibited a significant improvement in [the primary] objective outcome at 6 months and subjective outcomes at 1-year post treatment compared to standard of care," said Chee. Laborie Urology & Urogynecology 3.63K subscribers The Optilume urethral drug-coated balloon was developed in response to severe patient and physician dissatisfaction with current urethral. Elliott SP, Virasoro R, Estrella R, et al. Learn more about Optilume for Strictures Learn more about Optilume for BPH Post-Approval Study: Show Report Schedule and Study Progress . Nevertheless, endoscopic treatments still seem to have sub-optimal outcomes with high stricture recurrence rates. The drug-coated balloon may offer an intermediate step prior to repeated dilations, urethrostomies, or urethroplasty. 1 The approval was based on data from the ROBUST I and ROBUST 3 clinical trials. urotronic has introduced a drug coated balloon catheter to treat TOPICS . Change in IPSS score at 3-month post-procedure follow-up; 2). The device is used to treat patients with obstructive urinary symptoms associated with anterior urethral stricture. After treatment with the Optilume urethral drug-coated balloon (DCB), subjects were followed through 1 year. The distal end of the catheter has a semi- compliant inflatable balloon that is coated with a proprietary drug . Patients were evaluated within 14 days, three, six . For patients who have failed prior endoscopic treatment, today there is Optilume a breakthrough urethral drug-coated balloon treatment that dilates the urethral lumen and delivers paclitaxel directly to the stricture, significantly reducing the incidence of stricture recurrence. the Safety and Efficacy of the Optilume Drug-Coated Balloon in a Real-World Setting" and "Evaluation of the Impact of the Optilume Urethral Drug Coated Balloon on Semen Characteristics Post-Treatment" studies, as follows: PAS Progress Reports every six (6) months until subject enrollment has been completed, and annually thereafter. Territory Manager/Field Sales Trainer Uro Pathway West - Optilume Urethral Drug-Coated Balloon, Eclipse non-surgical Fecal Incontinence Solution, Urgent PC, Macroplastique, Portascan 3D Bladder Scanner . Source: Urotronic Inc. Brief Summary: Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 55 years of age. Congratulations to Dr. Craig Hunter and the staff at Mountain View Hospital for performing the first #Optilume procedure in Las Vegas! Territory Manager/Field Sales Trainer Uro Pathway West - Optilume Urethral Drug-Coated Balloon, Eclipse non-surgical Fecal Incontinence Solution, Urgent PC, Macroplastique, Portascan 3D Bladder Scanner . The Optilume drug-coated balloon is designed to provide quick and lasting relief for men suffering from urethral strictures. 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. The Optilume BPH Catheter System is comprised of two balloon catheters; a pre-dilation balloon to initiate the anterior commissurotomy and a drug-coated balloon to further dilate and. This treatment modality is a promising alternative to current endoscopic management and an option for patients that Paclitaxel, the drug that coats the balloon, is an antiproliferative - specifically designed to stop persistent cell division (proliferation). The ROBUST I study investigates the safety and efficacy of the Optilume DCB for the . This proprietary technology combines balloon dilation and drug delivery, and is well-tolerated by patients. The operation and follow-up were without complications. The Optilume was developed in response to severe patient and physician dissatisfaction with current . Plymouth, Minnesota-based Urotronic designed the paclitaxel-coated balloon to inhibit new scar tissue growth that can occur after endoscopic dilations. PMID: 34854748. Potential for long-term relief. 2021 Dec 2:101097JU0000000000002346. Thank you for offering . The new Optilume technology is developed for patients and physicians that are not satisfied with the current solutions available for the treatment of urethral strictures. The Optilume Drug Coated Balloon (DCB) is a guidewire compatible catheter with a tapered atraumatic tip. Description: The Optilume Drug Coated Balloon (DCB) is a guidewire compatible catheter with a tapered atraumatic tip. On December 13 2021, the US FDA approved the Optilume balloon for use in male urethral strictures. 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. Stop by and learn more about Optilume Ureathral Drug Coated Balloon intended for the treatment of strictures in the anterior urethra in adult males. Study device is Optilume BPH Prostatic Drug Coated Balloon Dilation Catheter System. Major device or procedure related complications at 3-month post-procedure follow-up. Study primarily outcomes are measured by 1). Optilume was granted CE mark approval for use in urethral strictures in 2020. Wir freuen uns auf Sie! A urethral stricture is a scar in or around the urethra that can restrict the flow of urine from the . Study device is Optilume BPH Prostatic Drug Coated Balloon Dilation Catheter System. The Optilume technology provides a low cost, minimally invasive treatment option for men suffering from urethral stricture. One-Year Results for the ROBUST III Randomized Controlled Trial Evaluating the Optilume Drug-Coated Balloon for Anterior Urethral Strictures. "The novel drug-coated balloon may represent a breakthrough in the endoscopic management of recurrent anterior urethral stricture disease." With both products, the Optilume drug coated balloon is used to exert gentle radial force to dilate the urethra to overcome the narrowed obstruction present before treatment providing greater flow of urine exiting the body. 3 ).