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
- Mean IPSS improved from baseline by at least 13.5 points (p<0.0001).
- Quality of life and BPH Impact Index scores were improved (>60% and >70%, respectively at 3, 6, and 12 months, p<0.0001).
- Mean Qmax improvement ranged from 90-129% (p<0.0001). At one month, 80% of men (95% CI 66- 89%) reported being ‘much’ or ‘very much better,’ and 89% (95% CI 76-95%) would recommend the procedure.
- Bother due to ejaculatory function improved rapidly and remained modestly improved at one year (p=0.001). No patient reported de novo sustained ejaculatory or erectile dysfunction.
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 cutting, heating, or removing prostate tissue. The UroLift System is the only leading BPH procedure shown to not cause new onset, sustained erectile or ejaculatory dysfunction in the L.I.F.T pivotal study.2-5 Most common adverse events are temporary and can include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence.2 Rare side effects, including bleeding and infection, may lead to a serious outcome and may require intervention. As with any medical procedure, individual results may vary. Consult the Instructions for Use (IFU) for more information. 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 200,000 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.**2,4,5 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.
+Dr. Steven Gange is a paid consultant of NeoTract/Teleflex
For Teleflex Incorporated:
Jake Elguicze, 610.948.2836
Treasurer and Vice President, Investor Relations
Nicole Osmer, 650.454.0504
1. Rukstalis et. al, Prostate Cancer and Prostatic Diseases 2018 MedLift Study
2. Roehrborn, J Urology 2013 LIFT Study
3. Roehrborn, Can J Urol 2017 5 Year LIFT Study
4. AUA BPH Guidelines 2003, 2020
5. McVary, J Sex Med 2016
*Management estimate based on product sales and average units per procedure
**No instances of new, sustained erectile or ejaculatory dysfunction in the L.I.F.T pivotal study
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