StimSite Gets Safer Technologies Program Designation

Allotrope Medical has received the FDA’s Safer Technologies Program (STeP) designation for its StimSite surgical device, which helps surgeons locate and identify the ureter during abdominal surgery, reducing post-surgery cystoscopy time.

StimSite, which gained FDA clearance in 2020, uses low-powered electrical stimulation to generate visible movement of the ureter, the tube that carries urine from the kidneys to the bladder.

The device is used during lower abdominal and pelvic procedures, including hysterectomies, endometriosis excisions and colon resections, when awareness and verification of the ureter during surgery is needed.