SILVER SPRING, Md. -- An implanted suture-based system to help men with enlarged prostates urinate more freely has been approved by the FDA, the agency said Friday.
The UroLift system, made by of Pleasanton, Calif., is "the first permanent implant to relieve low or blocked urine flow in men age 50 and older with an enlarged prostate," the .
By pulling back prostate tissue that presses on the urethra, the system allows more natural urine flow. An inserter is pushed through the urethra into the prostate gland to deploy flexible sutures. These sutures extend through the prostate to retract the tissue from the urethra, and are held in place by toggles at each end.
"The UroLift provides a less invasive alternative to treating BPH [benign prostatic hyperplasia] than surgery," said Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health, in the statement. "This device also may offer relief to men who cannot tolerate available drug therapies."
Two clinical studies involving a total of 274 middle-aged and elderly men were the main basis for approval, the FDA indicated.
Across both trials, urine flow increased by about 30% with no change in residual urine in the bladder. Participants reported that their symptoms decreased and that quality of life improved in the 2 years following implant, according to the FDA.
The larger of these trials was reported earlier this year at the American Urological Association's annual meeting. It found that AUA Symptom Index scores declined by an average of 50% from baseline within 90 days of implant, with an 88% improvement relative to a placebo group.
The FDA noted that adverse effects occurred in the trials. None attributed to the device were serious, but some patients reported pain or burning during urination, increased urgency, decreased urine flow, incomplete bladder emptying, and blood in the urine.