공시 • May 23
Teleflex Incorporated Showcases New Clinical Data on Urolift System and Barrigel Rectal Spacer
Teleflex Incorporated announced the Interventional Urology Business Unit has released new clinical data across two major urological congresses, reinforcing the value of the UroLift System and Barrigel rectal spacer in improving patient-centered outcomes across benign prostatic hyperplasia (BPH) and prostate cancer care. Data presented at the 2026 American Urological Association (AUA) Annual Meeting in Washington, DC. May 15 – 18 and the European Society for Radiotherapy & Oncology (ESTRO) Congress held in Stockholm May 15 – 19 highlight early patient experience following BPH treatment with the UroLift System and sustained reductions in radiation-associated toxicity for prostate cancer patients who received Barrigel rectal spacer. At AUA 2026, 12-month findings from the CLEAR (Comparing UroLift Experience Against Rezum) randomized controlled trial, the first prospective, multicenter, head-to-head RCT comparing MISTs for BPH, were presented. The study evaluated key endpoints including catheter independence, symptom improvement, patient experience, and sexual function. Catheter independence from day three through day seven was significantly better among UroLift System patients compared to Rezum patients, with 3% requiring catheter versus 20% (p=.02) respectively. Early patient experience was better for the UroLift System patients compared to Rezum patients. UroLift System and Rezum subjects had similar durability through 12 months. Patients’ sexual function was preserved through 12 months with the UroLift System. At ESTRO 2026, new three-year outcomes highlighted the long-term safety and effectiveness of Barrigel rectal spacer. Patients in the Barrigel rectal spacer arm of the study experienced a continued Grade 2+ toxicity benefit sustained through three years. Zero percent of the Barrigel rectal spacer patients experienced Grade 2+ toxicity versus 10% in the control arm. Fewer patients with greater than one centimeter of apical spacing had a decline in bowel quality of life at 36 months versus control. The UroLift System is a minimally invasive treatment for lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). It is indicated for the treatment of symptoms of an enlarged prostate up to 100cc in men 45 years or older (50 years outside U.S.). The UroLift System permanent implants, which can be delivered during an outpatient procedure, relieve prostate obstruction without heating, cutting, destruction of, or removing prostate tissue. The UroLift System can be used to treat a broad spectrum of anatomies, including obstructive median lobe. It is the only leading BPH procedure shown to not cause new onset, sustained erectile or ejaculatory dysfunction. A study conducted over five years showed a low retreatment rate of about 2% to 3% per year, or a total of 13.6% over the course of the study, demonstrating UroLift System durability. Most common side effects are temporary and can include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence. Rare side effects, including bleeding and infection, may lead to a serious outcome and may require intervention. Individual results may vary. The prostatic urethral lift procedure (using the UroLift System) is recommended for the treatment of BPH in both the 2021 American Urological Association and 2022 European Association of Urology clinical guidelines. More than 500,000 men have been treated with the UroLift System in select markets worldwide. The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men 45 years or older with prostates =100 cc. Contraindicated in men with current gross hematuria, urinary tract infection, urinary incontinence due to incompetent sphincter, and urethral conditions that prevent device insertion. Most common side effects are temporary and include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence. Rare side effects, including bleeding and infection, may lead to a serious outcome and may require intervention. Individual results may vary. Barrigel rectal spacer is the first and only hyaluronic acid rectal spacer that separates the prostate from the rectum to protect the rectum during radiation therapy treatment for prostate cancer. Barrigel rectal spacer is made from Non-Animal Stabilized Hyaluronic Acid (NASHA). Hyaluronic acid is a substance naturally present in the human body and is highly biocompatible and fully absorbable. NASHA has a proven history of safety and efficacy in a wide variety of medical applications in men, women and children worldwide. Barrigel rectal spacer has been proven to significantly reduce unwanted side effects from prostate cancer radiation therapy and is cleared for rectal spacing in the United States, Australia, and Europe. Barrigel rectal spacer is indicated for prostate cancer patients with T1-T3b disease. Barrigel rectal spacer is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and, in creating this space, the intent is to reduce the radiation dose delivered to the anterior rectum. It is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment and is intended to be absorbed by the patient’s body over time. It should only be administered by qualified and properly trained physicians with experience in ultrasound guidance and injection techniques in the urogenital/pelvic area. Potential complications include but are not limited to: pain associated with the injection; needle penetration or injection of Barrigel rectal spacer into the bladder, prostate, rectal wall, rectum, urethra, or intravascularly; local inflammatory reactions; infection; urinary retention; rectal mucosal damage, ulcers, necrosis; bleeding; constipation; and rectal urgency. Contraindicated in prostate cancer patients with clinical stage T4 disease. Individual results may vary.
