The US Food and Drug Administration (FDA) today 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 an
enlarged prostate.
The UroLift system relieves the
urine flow by pulling back the prostate tissue that is pressing on the urethra.
"The UroLift provides a less
invasive alternative to treating [benign prostatic hyperplasia] than
surgery," Christy Foreman, director of the Office of Device Evaluation at
the FDA's Center for Devices and Radiological Health, said in a release.
"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 2 clinical studies of 274 men with BPH implanted with
2 or more UroLift sutures. Both studies showed that physicians successfully inserted
UroLift in 98% of participants.
The studies also 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 after treatment.
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.
Severe BPH can lead to serious
problems over time, such as strain on the bladder, urinary tract infections,
bladder or kidney damage, bladder stones, and the inability to control urine
(incontinence). Current treatment options to relieve symptoms associated with
BPH include drug therapy or surgical procedures including removal of the
enlarged part of the prostate.
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.
The UroLift System is
manufactured by NeoTract Inc of Pleasanton, California.
