Device typeProstatic retraction implant: A sterile implantable device intended to increase prostatic urethral patency, and thereby relieve lower urinary tract symptoms (LUTS) due to benign prostatic hypertrophy (BPH), by physically compressing the prostate gland by retraction. The implant is in the form of a two orthogonal tags (e.g., metal) held together by a suture (e.g., monofilament), and is introduced so that one tag is outside the prostatic capsule and the other is in the urethra, with the suture providing retraction. It is not intended to be explanted. The device is implanted using a dedicated, single-use, hand-held, pistol-like delivery device through the sheath of a rigid endoscope.
FDA categoryImplantable transprostatic tissue retractor system
Device ID10814932020459
Catalog numberUL2ATC-C
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Conditional