FDA approves UroLift System for BPH

The FDA has on 13 September 2013 authorized the marketing of the UroLift system from Neotract Inc, the first permanent implant to relieve low or blocked urine flow in men age 50 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 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 a minimally invasive device designed to open the urethra directly without the need to resect or ablate prostate tissue. Deployed through the UroLift Delivery Device, permanent UroLift Implants are placed transurethrally to retract the obstructing prostatic lobes while leaving the prostate intact.