Barrigel Rectal Spacer Expands Contouring Capabilities Through Radformation Partnership
July 23, 2026 – Wayne, Pa. – Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced that its Interventional Urology business’ Barrigel™ rectal spacer is now available as a contouring structure option within Radformation's AutoContour v2.7 software. FDA-cleared in March 2026, the software version enables dosimetrists and physicians to efficiently contour Barrigel spacer during the treatment planning process for prostate radiation therapy.1 The AI model was trained using patient MRI and CT datasets from the Barrigel Pivotal Trial, obtained from 11 different institutions and centrally reviewed for consistent contour quality.1,2
In parallel with Teleflex's long-term strategy to significantly streamline the Teleflex business and narrow focus to the critical care and high-acuity hospital end-markets, the company's Interventional Urology business unit continues to drive clinical value as it prepares for its divestiture in the second half of 2026.
“Consistent and efficient contouring are critical components of prostate radiation treatment planning,” said Michelle Svatos, PhD, Director, Scientific Research Strategy and Innovation, Interventional Urology. “Integrating Barrigel rectal spacer into Radformation's AutoContouring platform helps streamline clinician workflows while supporting precise treatment planning based on CT or MRI imaging. This integration is another step forward in our commitment to providing radiation oncology teams with tools that support both procedural efficiency and positive patient outcomes.”
Barrigel rectal spacer is the only sculptable spacer, allowing physician-controlled spacing for a safe, symmetric, and stable placement.2-7 By helping reduce radiation exposure to healthy rectal tissue, Barrigel rectal spacer may help patients maintain bowel function, quality of life, and minimize treatment-related rectal side effects.8
Clinical evidence continues to demonstrate the long-term benefits of Barrigel rectal spacer in protecting healthy rectal tissue during prostate radiation therapy.8 In May 2026, three-year data from the Barrigel Pivotal Trial presented at ESTRO 2026 showed that zero patients treated with Barrigel rectal spacer experienced Grade 2 or greater gastrointestinal toxicity, compared with 10 percent in the control arm.⁸ Additionally, patients with greater than 1 cm of apical spacing experienced less decline in bowel quality of life at 36 months, reinforcing the critical role of rectal spacing in preserving long-term bowel function after treatment.⁸
"This collaboration represents another step in making AI-trained contouring more comprehensive and clinically relevant. By incorporating Barrigel rectal spacer into AutoContour, we're helping radiation oncology teams achieve consistent contouring across CT, MR and CBCT while integrating seamlessly into the treatment planning workflow,” said Christine Gnaster, Vice President of Product, Radformation. “It's part of our broader commitment to delivering automation that improves efficiency without changing how clinicians work.”
On Dec. 09, 2025, Teleflex announced it has entered into definitive agreements to sell the company’s Acute Care, Interventional Urology and OEM businesses to two buyers, Intersurgical® Ltd with respect to Acute Care and Interventional Urology, and Montagu and Kohlberg with respect to OEM.
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 (USA) law restricts this device to sale by or on the order of a physician.
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 Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. © 2026 Teleflex Incorporated. All rights reserved. APMC015A
*Studies sponsored by Teleflex.
†One or more authors have/had a financial relationship with Teleflex.
About Radformation
Radformation is committed to improving the lives of clinicians by delivering user-friendly products developed to increase the safety and quality of cancer treatment. Radformation envisions a radiation oncology clinic where staff are equipped with solutions that supplement their expertise and automate time-consuming tasks, leading to better patient care everywhere. Since its founding in 2016, Radformation has grown to serve over 2,000 clinics around the world in 28 countries with a portfolio of products accelerating all stages of the treatment planning workflow. For more information, visit radformation.com.
References
- U.S. Food and Drug Administration. K260509: AutoContour (RADAC V5) 510(k) decision letter. Published March 19, 2026. Accessed July 6, 2026.
- Mariados NF, Orio PF III, King M et al. JAMA Oncology (2023)*,
- Barrigel Injectable Gel Instructions for Use (2022)
- Svatos M, Chell E, Low DA et al. Medical Physics (2024)*,†
- Data on file Teleflex. 2025
- Williams J, McMillan K, Chao M et al. Journal of Medical Imaging and Radiation Sciences (2022)†
- Gejerman G, Goldstein MM, Chao M et al. Practical Radiation Oncology (2023)†
- 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 (ESTRO) 2026 Annual Congress; May 2026; Stockholm, Sweden. Proffered Paper 3623.
Contact:
Nigel Smith
983 Group
nigel@983group.com
781.308.3317
