<img height="1" width="1" style="display:none" src="https://www.facebook.com/tr?id=896170837107954&amp;ev=PageView&amp;noscript=1">

Teleflex Announces Large-Scale Analysis of Real-World Healthcare Claims Data for Enlarged Prostate Procedures at the American Urological Association 2021 Annual Meeting

Late-Breaking Data Presentation Reveals How UroLift PUL’s Post-Operative Events Compare With Other Minimally Invasive Procedures and Traditional Surgery for the Treatment of BPH

Read More

Teleflex Unveils the UroLift Advanced Tissue Control (ATC)® System and the UroLift® 2 System and Real-World Data Presentations at the American Urological Association 2021 Annual Meeting

New real-world data findings along with new product evolutions demonstrate why the UroLift® System is the right solution for most BPH patients

WAYNE, PA. – September 9, 2021 – Teleflex Incorporated (NYSE: TFX) today announced that two new UroLift System products, the UroLift Advanced Tissue Control (ATC) System and the UroLift 2 System, will be launched at the American Urological Association (AUA) 2021 Annual Meeting taking place virtually September 10–13. New emerging data from the largest analysis of U.S. healthcare claims within the field of benign prostatic hyperplasia (BPH) comparing complication rates (defined as a post-operative procedure performed during a return visit to an outpatient setting) and surgical retreatment rates of BPH procedures, including the UroLift System, will also be presented.

Read More

New Study Provides Insights into the Biocompatibility and Durability of the UroLift® System in Improving Benign Prostatic Hyperplasia Symptoms

WAYNE, Pa., August 20, 2021 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX) today announced the publication of clinical data for the UroLift® System in the peer-reviewed journal Prostate Cancer and Prostatic Disease. This study explains the mechanism of action through which the UroLift System provides long-term durability and sustained results for patients with benign prostatic hyperplasia (BPH), also referred to as enlarged prostate.

The UroLift System implants provide rapid relief from disruptive lower urinary tract symptoms (LUTS) through a minimally invasive procedure that pulls back enlarged prostate tissue. This published study is unique in its amalgamation of three different facets of research by including pre-clinical canine tissue, human tissue, and post-market surveillance data. Tissue samples were examined from twenty-four healthy canines and four human patients who were implanted with the UroLift System. Researchers reviewed the microscopic structure on all tissue samples to uncover any potential changes attributed to the implants.

The microscopic evaluation found that the extracted tissues revealed normal-appearing tissue with minimal-mild inflammation and no encrustation, indicating a stable and normal healing response. The data support a long-term biological mechanism of action whereby compression-induced localized tissue remodeling is initiated by the UroLift System implant placement and leads to a widened prostatic urethra. Furthermore, post-market surveillance data of over 770,000 UroLift System devices support that the implant is stable and remains fixed after proper deployment, and demonstrate low rates of breakage (0.004%) and encrustation (0.006%). Taken together, the biocompatibility and stability of the UroLift System implants appear to be superior to prostatic stents, with studies of prostatic stents showing that up to 47% of men require removal of their implants due to complications associated with migrations and encrustations.1

The UroLift implant pulls the enlarged prostate toward the capsule, thereby mechanically creating an immediate, visible deobstruction in the prostatic urethra. The researchers discuss this “prostate lift” is a fundamentally distinct mode of action compared with not only prostatic stents, but also thermal ablation techniques that induce tissue damage and may result in extended periods of edema, retention/catheterization, and higher risks of urinary infections and ejaculatory dysfunction. 2,3,4,5,6,7

“The UroLift System is the first mechanical prostatic implant to demonstrate safe and effective treatment of BPH without common issues associated with prior stents. This study describes in detail the unique prostate lift mechanism of action that is the basis of its durable outcomes,” said Dr. Peter Chin, Clinical Associate Professor, Graduate School of Medicine, University of Wollongong, and author on the paper. “Not only are the results seen with the UroLift System sustainable, but the implants can provide a superior patient experience during the early recovery period4, and rapid symptom relief and preservation of sexual function*”9

“More than 12 million men in the U.S. are treated for BPH/LUTS. With over 250,000 patients treated globally with the UroLift System, it has been the right solution for many patients,” said Jacqueline Welch, Medical Director of the Teleflex Interventional Urology business unit. “Physicians can implant the UroLift System with confidence due to the demonstrated long-term durability and sustained BPH relief that it provides.”10

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. The UroLift permanent implants, delivered during an outpatient procedure, relieve prostate obstruction without heating, cutting, destruction or removing prostate tissue. The UroLift System is the only leading BPH procedure shown to not cause new onset, sustained erectile or ejaculatory dysfunction.* 9,10,11,12 Most common adverse events are temporary and can include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence.9 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 American Urological Association and European Association of Urology clinical guidelines. More than 250,000 men have been treated with the UroLift System in select markets worldwide. Learn more at www.UroLift.com.

About Teleflex Interventional Urology
The Teleflex Interventional Urology Business Unit is dedicated to developing innovative, minimally invasive and clinically effective devices that address unmet needs in the field of urology. Our focus is on improving the standard of care for patients with BPH using the UroLift System, a minimally invasive permanent implant system that treats symptoms while preserving sexual function.*9-11 Learn more at NeoTract.com.

About Teleflex Incorporated
Teleflex is a global provider of medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, surgical, anesthesia, cardiac care, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit Teleflex.com.

Teleflex is the home of Arrow®, Deknatel®, LMA®, Pilling®, Rusch®, UroLift® and Weck® – trusted brands united by a common sense of purpose.

+Dr. Chin was an investigator for the PUL feasibility clinical trial and the LIFT pivotal study. He is also a paid consultant for NeoTract Inc./Teleflex.

Read More

Largest U.S. Healthcare Claims and Utilization Analysis for BPH Procedures Reveals Lowest Overall Complication Rates and Consistent Durability after Treatment with Minimally Invasive UroLift System

Real-World Claims Data Presented at Annual European Association of Urology Congress Reveal Overall Complication Rates are Lowest after Treatment with the UroLift System

Read More

Teleflex Announces Real-World Clinical Data Presentations of the UroLift® System at the 36th Annual European Association of Urology Congress

Presentations to Provide New Insights on the Real-World Effectiveness and Durability of Leading Minimally Invasive Procedure for Enlarged Prostate

Read More

New Data Suggest Men with Urinary Symptoms Often Anticipate Bathroom Needs and Avoid Events and Activities They Enjoy

Teleflex survey finds “extreme bathroom planning” to accommodate urinary symptoms common with an enlarged prostate (BPH) impacts daily activities

Read More

Teleflex Reports 250,000 Patients Treated for Enlarged Prostate With the Minimally Invasive UroLift® System

WAYNE, Pa., March 9, 2021 (GLOBE NEWSWIRE) – Teleflex Incorporated (NYSE: TFX) today announced that, globally, 250,000 patients have been treated with the UroLift® System, a proven, minimally invasive approach to treating benign prostatic hyperplasia (BPH).

In the United States alone, more than 42 million men are affected by BPH and approximately 12 million men are under a doctor’s care for the condition.1 This common, non-cancerous enlargement of the prostate occurs as men age and can interrupt sleep, cause urinary problems, and decrease quality of life.2

“The UroLift System is a standard of care in my practice, and I confidently recommend it to appropriate patients who face the challenge of an enlarging prostate,” said Wayne Kuang, M.D.a “Many men are looking for alternatives to medications and major surgeries that have unwanted side effects and risks. The UroLift System may enable men to experience rapid symptom relief, recover from the procedure quickly, and return to their normal routines with minimal downtime.3,4 This minimally invasive procedure can achieve consistent results in a broad range of BPH patients with various anatomies and a wide range of sizes.”

“Celebrating 250,000 patients treated with the UroLift System is an exciting milestone. We thank the physicians in our community who recommend the UroLift System to their patients,” said Tyler Binney, President of the Teleflex Interventional Urology business unit. “Recent clinical data show the UroLift System provides a superior patient experience with better sexual function, lower catheterization rates, less interference with daily activities, and higher patient satisfaction in the early recovery period.b,5 Patients treated with the UroLift System may also achieve better outcomes in sexual function and satisfaction than men who receive medical therapyc,8 These positive UroLift System outcomes align with our goal at Teleflex to improve the health and quality of patients’ lives.”

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. The UroLift permanent implants, delivered during an outpatient procedure, relieve prostate obstruction without heating, cutting, destruction or removing prostate tissue. The UroLift System is the only leading BPH procedure shown to not cause new onset, sustained erectile or ejaculatory dysfunction.d,3,6,7 Most common adverse events are temporary and can include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence.3 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 American Urological Association and European Association of Urology clinical guidelines. More than 250,000 men have been treated with the UroLift System in select markets worldwide.e Learn more at www.UroLift.com.

About Teleflex Interventional Urology
The Teleflex Interventional Urology Business Unit is dedicated to developing innovative, minimally invasive, and clinically effective devices that address unmet needs in the field of urology. Our focus is on improving the standard of care for patients with BPH using the UroLift® System, a minimally invasive, permanent implant system that treats symptoms while preserving sexual function.d,3,6,7 Learn more at www.NeoTract.com.

About Teleflex Incorporated
Teleflex is a global provider of medical technologies designed to improve the health and quality of people’s lives. We apply purpose-driven innovation—a relentless pursuit of identifying unmet clinical needs—to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, surgical, anesthesia, cardiac care, urology, emergency medicine, and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit www.Teleflex.com.

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rusch®, UroLift® and Weck®—trusted brands united by a common sense of purpose.

Read More

Published Data Demonstrate Sexual Function Improvement and Preservation with the Minimally Invasive UroLift® System Compared to Medications Prescribed for Benign Prostatic Hyperplasia

WAYNE, Pa.— January 20, 2021—Teleflex Incorporated (NYSE: TFX) announced today that new data published in the peer-reviewed journal, European Urology Focus, found that men treated with the Prostatic Urethral Lift (PUL) procedure (using the UroLift® System) showed preservation and some improvement of sexual function compared to men being treated with medication for benign prostatic hyperplasia (BPH).

The comparative analysis “Prostatic Urethral Lift vs. Medical Therapy: Examining the Impact on Sexual Function in Men with BPH,” is the first study to longitudinally compare sexual function outcomes between major PUL studies1-4 and data from the Medical Therapy of Prostatic Symptoms (MTOPS) trial. Treatment-related changes in sexual function were reported by validated patient questionnaires. In this comparison, researchers demonstrated that the UroLift System procedure maintained sexual function among sexually active men in all three domains (erectile function, ejaculatory function, and sexual satisfaction) that were examined, and even improved sexual function at certain timepoints. This was in contrast to daily treatment with an alpha blocker (doxasozin), 5-alpha-reductase inhibitor (finasteride), either alone or in combination with each other. This study was sponsored by Teleflex Incorporated.

“Within this comparative analysis examining the impact of PUL or medical therapy on male sexual health, we challenge the idea that medical therapy is the most conservative minimally invasive treatment option for BPH patients,” said Claus G. Roehrborn+, M.D., Urologist at the University of Texas Southwestern Medical Center and a lead author on the paper. “The results show that the sexual health preservation benefits provided by the UroLift System were not seen with medication. The UroLift System can provide rapid relief for the symptoms of BPH while sustaining and sometimes even improving sexual function.”

Mean percent changes in erectile function, ejaculatory function, and sexual satisfaction from patient reported questionnaires were analyzed to determine improvements in sexual function. Key findings include:

Read More

Research Reinforcing the Effectiveness and Safety of the UroLift® System in the Real-World Setting Presented at 50th Annual ICS Meeting

New Findings Show UroLift System Same-Day Outpatient Procedure Demonstrates Symptom Improvement for Benign Prostatic Hyperplasia

Read More

Teleflex Interventional Urology Expands Portfolio with Introduction of the UroLift® Advanced Tissue Control (ATC)™ System

WAYNE, Pa., – October 28 2020 – Teleflex Incorporated (NYSE: TFX) today announced the expansion of its UroLift® System portfolio with the introduction of the UroLift® Advanced Tissue Control (ATC)™ System. The new system, which builds on the highly successful UroLift System, features a number of enhancements to enable urologists to more easily treat benign prostatic hyperplasia (BPH) patients with challenging anatomies, including an obstructive median lobe and large lateral lobes. The UroLift ATC System will be launched on a limited basis while the business unit expands its capacity to meet demand.

The UroLift ATC System was cleared by the U.S. Food and Drug Administration (FDA) in June 2020 to treat BPH, including lateral and median lobe hyperplasia, in prostates up to 100cc in men 45 years of age or older. The standard UroLift System was previously cleared by the FDA in late 2017 for median lobes. Although only a small percentage of patients have an obstructive median lobe, the UroLift ATC System further enhances the ability to treat these anatomies.

The new UroLift ATC System delivers the same proven UroLift implant through an enhanced delivery device tip. It features tissue control wings that hold tissue during manipulation, enabling the urologist to mobilize obstructive tissue and pin it to the side to enhance visualization and open up the blockage caused by the enlarged prostate. The tissue control wings are strategically shaped to optimize the view of obstructing tissue. The UroLift ATC System also includes a needle location marker with laser-etched markings that can aid with targeting accuracy for predictable implant placement.

“We are encouraged by early positive responses from urologists to the UroLift ATC System. Urologists are reporting high satisfaction with its ease of use and indicating their willingness to adopt the new device in their practices to treat patients with challenging anatomies, including obstructive median lobe and large lateral lobes,” said Dave Amerson, president of the Teleflex Interventional Urology business unit.

“My experience with the UroLift ATC System has been overwhelmingly positive,” said Steven Gange, M.D.+, Salt Lake City, Utah. “The new design features of the UroLift ATC System make it easier for me to treat patients with complex anatomies, and especially increase my confidence in treating patients with an obstructive median lobe.”

The UroLift System has consistently achieved statistically significant results in patients with an obstructive median lobe; the new UroLift ATC System will make it easier to handle the more complex anatomy of these patients. Data published from the MedLift Study showed that patients who were treated for obstructive median lobe with the standard UroLift System experienced significant improvements in IPSS (International Prostate Symptom Score), Qmax (peak flow rate), and QoL (quality of life) scores:1

Read More