The FDA has authorized the marketing of the UroLift system, the first permanent implant to relieve low or blocked urine flow in men aged 50 years and older with BPH.
The FDA authorized the marketing of the UroLift system, the first permanent implant to relieve low or blocked urine flow in men aged 50 years and older with BPH.
The UroLift system, manufactured by NeoTract Inc. of Pleasanton, CA, involves the insertion of permanent implants into the prostate to retract the lobes away from the prostatic urethra. (An online videoshows key steps in the implant technique.)
“The UroLift provides a less invasive alternative to treating BPH than surgery,” said Christy Foreman, of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “This device also may offer relief to men who cannot tolerate available drug therapies.”
The FDA’s review of the UroLift system included data from two clinical studies of men with BPH implanted with two or more UroLift sutures. The first study included 64 men between the ages of 53 and 83 years, and the second study included 210 men between the ages of 49 and 86. Both studies showed that physicians successfully inserted UroLift in 98% of participants.
The studies also measured participant urine flow and ability to empty the bladder, and throughout the study period, found a 30% increase in urine flow and a steady amount of residual urine in the bladder. Study participants answered validated questionnaires about their BPH-related symptoms and quality of life, reporting a decrease in symptoms and an increase in quality of life in the 2 years following treatment.
“There is rapid and significant symptom improvement, improved urinary flow rate, and preserved sexual function,” said Claus G. Roehrborn, MD, of the University of Texas Southwestern Medical Center in Dallas, who presented data from the second of the two pivotal FDA studies at the AUA annual meeting in San Diego. “All primary and secondary endpoints were met, and durability at 1 year was established.”
Minor adverse events reported included pain or burning during urination, blood in the urine, frequent or urgent need to urinate, incomplete emptying of the bladder, and decreased urine flow. Investigators did not report any serious device-related adverse events.
The FDA reviewed the UroLift system through its de novo classification process, a regulatory pathway for some novel low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device.
Dr. Roehrborn is a consultant/adviser for NeoTract.
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