Teleflex Showcases New Clinical Data at Leading Urological Congresses Highlighting Patient Experience Advantages of the UroLift™ System and Long-Term Toxicity Reduction with Barrigel™ Rectal Spacer
First Head-to-Head Randomized Control Study (RCT) Reinforces Early Patient Experience Benefits and 12-month Durability of the UroLift™ System versus Rezūm™1
Three-Year Data Demonstrate Sustained Reduction in Gastrointestinal Toxicity with Barrigel™ Rectal Spacer2
In parallel with Teleflex’s long-term strategy to significantly streamline the
Data presented at the 2026
CLEAR RCT: First Head-to-Head Comparison of Minimally Invasive Surgical Therapies (MISTs) Demonstrates Favorable Early Patient Experience with the UroLift™ System*
At AUA 2026, Dr.
The study evaluated key endpoints including catheter independence, symptom improvement, patient experience, and sexual function.1
Key study endpoints of the study:
- Catheter independence from day three through day seven was significantly better among UroLift™ System patients compared to Rezūm™ patients, with 3 percent requiring catheter versus 20 percent (p=.02) respectively1
- Early patient experience was better for the UroLift™ System patients compared to Rezūm™ patients1
- UroLift™ System and Rezūm™ subjects had similar durability through 12 months1
- Patients’ sexual function† was preserved through 12 months with the UroLift™ System1
“What stands out in our CLEAR RCT study is the consistency of the early patient experience advantages with the UroLift™ System, particularly catheter independence, rapid recovery, and preservation of sexual function, which are critical factors for both patients and physicians when selecting a treatment approach,” said Dr.
Barrigel™ Rectal Spacer Three-Year Data Demonstrate Sustained Reduction in Radiation-Associated Toxicity*
At ESTRO 2026, new three-year outcomes presented by Dr.
Key endpoints of the study:
- 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 percent in the control arm2
- Fewer patients with greater than one centimeter of apical spacing had a decline in bowel quality of life at 36 months versus control2
These results demonstrate a durable benefit for the Barrigel™ rectal spacer subjects sustained through three years, reinforcing the role of rectal spacing in protecting bowel function during and after radiation therapy.2
“The three-year data further validate the clinical value of Barrigel™ rectal spacer, demonstrating sustained and clinically meaningful reductions in gastrointestinal toxicity,” said
“These data reflect our prostate health leadership and ongoing commitment to advancing evidence-based, patient-centered solutions across the urology care continuum,” said
About the UroLift™ System
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
UroLift System Important Safety Information
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. Visit urolift.com.
About Barrigel™
Rectal Spacer
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.11 Barrigel™ rectal spacer is made from Non-Animal Stabilized Hyaluronic Acid (NASHA).12
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.13,14
Barrigel™ rectal spacer has been proven to significantly reduce unwanted side effects from prostate cancer radiation therapy11 and is cleared for rectal spacing in
Barrigel™ Rectal Spacer Important Safety Information
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. Visit barrigel.com.
Caution: Federal (
About Interventional Urology
The Interventional Urology Business Unit is leading in prostate health by advancing clinical evidence, elevating education, and supporting physicians and patients. Our portfolio includes Barrigel™ rectal spacer for men seeking to reduce rectal side effects associated with prostate cancer radiation therapy, the UroLift™ System for men suffering from BPH symptoms, and Deflux™ injectable gel for children with grades II-V vesicoureteral reflux (VUR).
Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Any forward-looking statements contained herein are based on our management's current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements. These risks and uncertainties are identified and described in more detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K.
Barrigel, Deflux, and UroLift are trademarks or registered trademarks of
*Studies sponsored by
**Drs. Chughtai and King are paid consultants of
†No instances of new, sustained erectile or ejaculatory dysfunction in the L.I.F.T. pivotal study
References
- Chughtai et al. J Urol 2026
-
King M, Chao M et al. Prospective Randomized Controlled Trial of Hyaluronic Acid Spacer for Hypofractionated Prostate Radiation Therapy: 3-Year Results. Presented at:
European Society for Radiotherapy and Oncology 2026 Annual Congress;May 2026 ;Stockholm, Sweden . Proffered Paper 3623. -
Shore, Can
J Urol 2014 - Rukstalis, Prostate Cancer Prostatic Dis 2018
- UroLift™ System Instructions for Use
- AUA BPH Guidelines 2003, 2020
- McVary, Urology 2019
-
Roehrborn, Can
J Urol 2017 - Roehrborn, J Urol 2013
-
Management estimate based on product sales as of
June 2024 . Data on file. Teleflex Interventional Urology. - Mariados NF, Orio PF III, King M et al. JAMA Oncol (2023)*,**
- Barrigel Injectable Gel Instructions for Use (2022)
- Svatos M, Chell E, Low DA et al. Med Phys (2024)*,**
- Restylane® celebrates 25 years of natural-looking results with its signature line of hyaluronic acid fillers. 2021.
-
Data on file
Teleflex . 2025
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investor.relations@teleflex.com
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