UroLift 2 System with advanced tissue control launched for BPH

Teleflex Incorporated has announced the full market launch of the unified UroLift 2 System with Advanced Tissue Control (UroLift 2 ATC) for the treatment of patients with benign prostatic hyperplasia (BPH), according to a news release from the company.¹

The Urolift 2 ATC system is indicated for the treatment of patients with prostates of up to 100 g, lateral and median lobe hyperplasia, and aged 45 or older.

The Urolift 2 ATC system is a combined product of the company’s Urolift 2 System and the UroLift ATC System, which were commercially launched in the US in May 2022.²

“The UroLift 2 ATC is designed to deliver the same proven effectiveness of the UroLift System, with significant enhancements on a unified UroLift 2 platform,” said Brian Wilkins, vice president of research and development for Teleflex Interventional Urology, in the news release.¹ “Based on physician feedback, it maintains the efficacy of the UroLift System, improves overall performance, and offers physicians the advantage of efficiently treating a broader range of patients. This expanded capability offered by UroLift 2 ATC opens new avenues for patient care.”

The FDA granted 510(k) clearance to the UroLift 2 ATC System in September 2023.³

The Urolift 2 ATC system is indicated for the treatment of patients with prostates of up to 100 g, lateral and median lobe hyperplasia, and aged 45 or older. According to Teleflex, the unified system offers improved control of obstructive tissue and targeting accuracy, as well as a streamlined delivery system and individual implant cartridges.

“UroLift 2 ATC optimizes enlarged prostate treatment by providing urologists with unparalleled confidence and customization capabilities,” said Jake Newman, President, The Americas for Teleflex, in the news release.¹ “The UroLift 2 System with ATC offers a comprehensive solution for BPH care, combining cutting-edge technology with proven clinical outcomes. Our innovative platform streamlines procedures and eliminates the need to transition between platforms during a procedure. Enhanced features, including greater and more consistent implant compression and reduced waste, will help drive outcomes and efficiency in health care delivery.”

Data on the UroLift System

Data on the UroLift System were presented at the 2023 American Urological Association Annual Meeting in Chicago, Illinois.⁴ Overall, the study demonstrated that early treatment with the UroLift System before severe lower urinary tract symptoms led to long-term durability in patients with BPH.

The study included more than 330 patients who were treated with prostatic urethral lift with the UroLift System. At 5-year follow-up, 13.7% patients required surgical retreatment. This rate is consistent with that seen in the L.I.F.T. study, in which 13.6% of patients required surgical retreatment at 5 years.⁵

The study also showed that durability at 5 years was primarily affected by poor International Prostate Symptom Scores for obstructive symptoms at baseline. Further, poor durability at 1 year was associated with undertreatment, defined as 4 or less implants placed. No patients in the study who received 7 or more implants required surgical retreatment.

References

1. Teleflex Incorporated introduces the UroLift 2 System with advanced tissue control, a revolutionary unified platform designed to treat all prostate types. News release. Teleflex. Published online and accessed April 2, 2024. https://investors.teleflex.com/news/news-details/2024/Teleflex-Incorporated-Introduces-the-UroLift-2-System-With-Advanced-Tissue-Control-a-Revolutionary-Unified-Platform-Designed-to-Treat-All-Prostate-Types/default.aspx

2. Teleflex announces full U.S. commercial launch of the UroLift 2 System and UroLift ATC Advanced Tissue Control System. News release. Teleflex Incorporated. May 13, 2022. Accessed April 2, 2024. https://investors.teleflex.com/news/news-details/2022/Teleflex-Announces-Full-U.S.-Commercial-Launch-of-the-UroLift-2-System-and-UroLift-ATC--Advanced-Tissue-Control-System/default.aspx

3. 510(k) Premarket Notification. US Food & Drug Administration. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm

4. Roehrborn C, Gange S, Rochester M, Barber N, Chin P. Pooled analysis of 330+ subjects treated with the Prostatic Urethral Lift (PUL) reveals undertreatment impacts durability. Presented at 2023 American Urological Association Annual Meeting. Chicago, Illinois. April 28-May 1, 2023. Abstract PD41-06

5. Roehrborn CG, Barkin J, Gange SN, et al. Five year results of the prospective randomized controlled prostatic urethral L.I.F.T. study. Can J Urol. 2017;24(3):8802-8813