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Men with obstructive median lobes handled with the UroLift® System expertise symptom enchancment sooner and are happy extra shortly in comparison with these handled with TURP, and have fewer post-op catheterizations
WAYNE, Pa., Oct. 25, 2022 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX), a number one world supplier of medical applied sciences, introduced at present new information revealed in the peer-reviewed Journal of Endourology display the minimally invasive Prostatic Urethral Lift (PUL) process utilizing the UroLift® System yields constant security, effectiveness and affected person expertise outcomes for benign prostatic hyperplasia (BPH) with and with out obstructive median lobes.
The comparative evaluation, “Prostatic Urethral Lift for Obstructive Median Lobes: Consistent Results Across Controlled Trial and Real-World Settings,”* is the first to evaluate the UroLift® System in each medical settings and evaluate security, symptom, and affected person expertise outcomes to transurethral resection of the prostate (TURP) and sham remedies in managed settings.
“This analysis reinforces that the UroLift® System is an effective treatment option for men with BPH in prostates with and without obstructive median lobes,” stated Gregg Eure, M.D., Urologist at Urology of Virginia* and a lead creator on the paper. “Research directly comparing minimally invasive surgical procedures for BPH has been sparse, but by comparing results from randomized, controlled clinical trials and large real-world studies, we are able to achieve a robust view of the safety and effectiveness of PUL in treating obstructive median lobes and lateral lobe obstruction.”
Controlled medical trial outcomes of the UroLift® System for obstructive median lobes reveal that males who underwent PUL skilled higher symptom enchancment inside the first three months of remedy in comparison with these handled with sham and TURP in different managed research, and didn’t endure excessive grade critical hostile occasions. Ejaculatory perform scores for males handled with the UroLift® System have been additionally considerably higher than TURP in any respect timepoints.
PUL for obstructive median lobes in a real-world setting confirms managed medical trial outcomes following remedy with the UroLift® System. Symptom and uroflow outcomes have been largely constant for obstructive median lobe sufferers handled in managed and real-world settings; nonetheless, sufferers handled in a real-world setting skilled fewer post-operative catheterizations with out elevated hostile occasions. Furthermore, real-world security, symptom and affected person expertise outcomes have been equal between males with lateral and median lobe obstruction.
The comparative evaluation included sufferers throughout 3 managed medical research, together with the 5 12 months L.I.F.T. Trial and MedLift, an FDA-approved IDE extension of L.I.F.T., and 1 actual world retrospective examine. Specifically, outcomes of obstructive median lobe sufferers handled with the UroLift® System in managed (the MedLift examine, n=45) and real-world settings (i.e., the real-world retrospective examine of the UroLift® System, n=180) have been evaluated in opposition to comparator teams (topics with out obstructive median lobe handled with TURP [n=35] and sham [n=66] in randomized managed trials) to evaluate consistency in security, symptom response and affected person expertise. The L.I.F.T. examine has confirmed UroLift® System sturdiness out to five years with a surgical retreatment fee of 13.6% over 5 years or about 2-3% per 12 months. 2
“This is the kind of comparative data that urologists and men with BPH need to make informed choices about their treatment,” stated Kevin Hardage, President and General Manager of Teleflex Interventional Urology. “By weighing a wide range of controlled and real-world data, this vital analysis paints a broad picture of the safety and effectiveness of the UroLift® System for men with obstructive median lobes, and further shows significant advantages compared to TURP. These results give urologists and their patients increased confidence in the UroLift® System for the treatment of BPH.”
Key findings of the comparative evaluation embrace:
- UroLift® System vs sham: Subjects in the MedLift examine skilled 170% higher symptom enchancment at three months post-procedure to sham topics in the L.I.F.T. examine.
- UroLift® System vs TURP: Subjects in the MedLift examine had considerably higher enchancment (i.e., IPSS level change from baseline) at one and three months, and comparable enchancment at six and 12 months to TURP topics in the BPH6 trial. Significantly extra MedLift topics have been happy sooner after remedy (one and three months), whereas an identical fee of affected person satisfaction was noticed between MedLift and TURP topics at six and 12 months post-treatment. Ejaculatory perform and trouble scores have been considerably higher for MedLift topics in any respect time factors.
- Controlled vs real-world outcomes: Symptom enchancment was equal amongst MedLift examine topics and the filtered real-world obstructive median lobe group at three, six, and 12 months post-treatment.
About the UroLift® System
The UroLift® System is a minimally invasive remedy for decrease urinary tract signs as a result of benign prostatic hyperplasia (BPH). It is indicated for the remedy of signs of an enlarged prostate as much as 100 cc in males 45 years or older (50 years exterior U.S.). The UroLift® everlasting implants, which could be delivered throughout an outpatient process, relieve prostate obstruction with out heating, slicing, destruction of, or eradicating prostate tissue. The UroLift® System can be utilized to deal with a broad spectrum of anatomies, together with obstructive median lobe.1 It is the solely main BPH process proven to not trigger new onset, sustained erectile or ejaculatory dysfunction.**2-4 The L.I.F.T. examine has confirmed UroLift® System sturdiness out to five years with a surgical retreatment fee of 13.6% over 5 years or about 2-3% per 12 months.2 Most frequent hostile occasions are momentary and may embrace hematuria, dysuria, micturition urgency, pelvic ache, and urge incontinence.5 Rare unwanted side effects, together with bleeding and an infection, could result in a critical consequence and will require intervention. Individual outcomes could differ. The prostatic urethral carry process (utilizing the UroLift® System) is beneficial for the remedy of BPH in each the American Urological Association and European Association of Urology medical pointers. More than 350,000 males have been handled with the UroLift® System in choose markets worldwide.6 Learn extra at UroLift.com. Rx solely.
About Teleflex Incorporated
Teleflex is a world supplier of medical applied sciences designed to enhance the well being and high quality of individuals’s lives. We apply goal pushed innovation – a relentless pursuit of figuring out unmet medical wants – to learn sufferers and healthcare suppliers. Our portfolio is numerous, with options in the fields of vascular entry, interventional cardiology and radiology, anesthesia, emergency medication, surgical, urology and respiratory care. Teleflex workers worldwide are united in the understanding that what we do day by day makes a distinction. For extra info, please go to teleflex.com.
Contacts:
Teleflex Incorporated:
Lawrence Keusch
Vice President, Investor Relations and Strategy Development
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Vice President, Investor Relations
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610-948-2836
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Nicole Osmer
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650-454-0504
*The examine was sponsored by Teleflex Interventional Urology, and the authors, Drs. Gregg Eure, Claus Roehrborn, and Daniel Rukstalis, are paid consultants of Teleflex.
**No situations of recent, sustained erectile or ejaculatory dysfunction in the L.I.F.T. pivotal examine.
References:
1. Rukstalis, Prostate Cancer and Prostatic Dis 2018
2. Roehrborn, Can J Urol 2017
3. AUA BPH Guidelines 2003, 2021
4. McVary, J Sex Med 2016
5. Roehrborn, J Urology 2013
6. Management estimate based mostly on product gross sales as of April 2022. Data on file Teleflex Interventional Urology.
Teleflex is the dwelling of Arrow®, Deknatel®, LMA®, Pilling®, QuikClot®, Rüsch®, UroLift®, and Weck® – trusted manufacturers united by a standard sense of goal.
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