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FDA Approves Expanded Indication for BPH Treatment
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The NeoTract product was originally indicated to treat those with BPH aged 50 years and older.
The US Food and Drug Administration (FDA) has granted approval to the UroLift System for a new indication, to include patients with benign prostatic hyperplasia (BPH) that have an obstructive median lobe aged 45 years and older.
The NeoTract product was originally indicated to treat those with BPH aged 50 years and older.
“We are excited that more men with enlarged prostate are now eligible for treatment with the UroLift System,” Dave Amerson, the president of NeoTract and Teleflex Interventional Urology said in a statement. “The clinical data we have amassed on the UroLift System, including the five-year data from the L.I.F.T. IDE study, has solidified the product’s position as an important standard-of-care treatment for men with BPH and is further bolstered by these expanded indications. We are diligently training current UroLift users on how to treat obstructive median lobes with the UroLift System so they continue to see optimal patient outcomes.”
In 5-year clinical trial data involving. 206 subjects aged 50 years and older, the system was proven to be efficacious enough to allow male patients with BPH to get off medication for the condition and avoid major surgical procedures, while still maintaining sexual organ function.
The study, LIFT, showed high tolerability, sustained improvements in peak urinary flow rates, and rapid reduction of symptoms post-procedure, as well as improved quality of life—patients were back to preoperative physical activity after a mean of 8.6 days—and International Prostate Symptom Scale (IPSS) scores. IPSS scores were improved at a rate 88% greater than placebo after 3 months and shown to be durable through 5 years, with a 36% greater rate by that point.
The surgical retreatment rate was 13.6% over the 5-year period. Overall retreatment rates were “2-3% per year, which compares well to the 1-2% expected rate for the gold standard [transurethral resection of the prostate],” according to NeoTract.
BPH impacts roughly 40 million US men, and while medication exists as first-line therapy, many patients receive only temporary and insufficient relief. Surgical options, while efficacious, are also often coupled with permanent adverse effects.
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