A Digital Publication for the Practicing Medical Specialist, Industry Executive & Investor

No Carolina / New York

FDA Approves Optilume® Urethral Drug Coated Balloon

A breakthrough treatment for 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. Optilume was granted CE mark approval for use in urethral strictures in 2020.

A urethral stricture is a scar in or around the urethra that can restrict the flow of urine from the bladder and can result in a painful, frustrating slowing of the urinary stream. Strictures can be caused by infections, trauma, and other medical procedures that injure the lining of the urethra and can significantly impact patients’ quality of life. If left untreated, strictures can lead to serious complications, including bladder and kidney damage, infections, and poor ejaculation in men. Multiple endoscopic treatments of the same stricture are proven to lead to progressively worsening outcomes, recurrence, and retreatment.2

The Optilume paclitaxel-coated balloon technology was developed in response to patient and physician dissatisfaction with current endoscopic solutions for urethral strictures. Optilume works by inhibiting new scar tissue growth that often recurs after endoscopic dilations. This innovative, proprietary technology represents a significant paradigm change from the methods currently used by urologists to treat these conditions and provides a durable, low-cost, minimally invasive treatment option for millions of patients suffering from these conditions globally. Patients who suffer from urethral stricture undergo millions of dilations per year in the US alone.³

“As the ROBUST 1 and ROBUST 3 clinical trials demonstrated, Optilume significantly reduces the incidence of stricture recurrence,” said Dr. Sean Elliott, principal investigator for the Re-establishing Flow Via Drug-Coated Balloon for the Treatment of Urethral Stricture Disease (ROBUST) trials. “At three years, durability continued with a 77% freedom from reintervention rate, a 176% increase in Qmax, and a 65% decrease in IPSS. Optilume may serve as an important alternative for men with recurrent strictures that want to avoid or delay urethroplasty”.4

David Perry, President and CEO of Urotronic, Inc. stated, “We are excited to introduce Optilume to the US urology community and their patients who suffer from this debilitating disease. The technology has the potential to reduce burdens across the US healthcare landscape as a treatment that is easy to learn and can be performed as an outpatient procedure. Optilume is the treatment that breaks the cycle of recurrent urethral strictures.” https://optilume.com/

  1. Elliott SP, et al. MP56-07: Interim Results for the ROBUST III Trial Evaluating the Optilume Drug Coated Balloon for Anterior Urethral Strictures. J Urol 2021;206(3S):e971.
  2. Heyns CF, Steenkamp JW, De Kock MLS, Whitaker P. Treatment of male urethral strictures: is repeated dilation or internal urethrotomy useful? J Urol 1998;160:356-8.
  3. Santucci, RA Male Urethral Stricture Disease J Urol. 2007, May
  4. Data on file
Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

Dr. Michael Newman, Indaptus’ Founder, Chief Scientific Officer, and lead author, commented, “The new data are consistent with our preclinical animal tumor model studies and provide evidence for our hypothesis that patented Decoy bacteria can activate a wide range of innate and adaptive human immune cells involved in fighting tumors.  This aligns with what we’ve observed in our ongoing Phase 1 clinical trial of Decoy20 – broad immune activation, as evidenced by transiently increased levels of many key cytokines and chemokines following single dose administration. These findings bolster our confidence in Decoy20's potential as a multifaceted immunotherapy.”
To further understand the impact of platforms like TikTok on nutrition trends, MyFitnessPal partnered with Dublin City University on a research and experimental study that examined diet and nutrition content on TikTok. The study analyzed over 67,000 videos using Artificial Intelligence to compare them against public health and nutrition guidelines
Leveraging the power of Apple Vision Pro to seamlessly blend digital content with the physical world Osso Health brings the operating experience to life via detailed, clinically accurate workflows of common procedures.
“We are excited to present the first look at the safety and clinical activity of ELVN-001, which we believe supports the potential for ELVN-001 to address the limitations of the available active-site TKIs,” said Helen Collins, M.D., Chief Medical Officer of Enliven. “Across a wide dose range, ELVN-001 demonstrated activity in a heavily pre-treated patient population that includes post-asciminib patients, with a preliminary safety profile consistent with its highly selective design. Not only did all evaluable patients have improved or stable BCR::ABL1 transcript levels, but, importantly, 89% of all patients enrolled remain on study. We believe the initial data demonstrate the potential clinical utility of ELVN-001 for all types of patients, including those that are earlier in the treatment paradigm.”
The partnership is with Health-HavenRx ™, an online pharmacy platform. This partnership enables a new, convenient channel for patients to access POGO Automatic by using their health insurance on Intuity Medical’s e-commerce website at www.GoodtoPogo.com.

By using this website you agree to accept Medical Device News Magazine Privacy Policy