Allotrope Medical this week said it received FDA clearance for its StimSite.
The device is designed to help surgeons locate and identify ureters during surgery. StimSite provides electrical stimulation to ureter smooth muscle tissue by testing ureter smooth muscle excitability. It can be used by OB/GYNs, general and colorectal surgeons with existing surgical instruments.
“Whether it is a gynecologic or colorectal operation, a significant portion of OR time is spent looking for the Ureter and keeping it safe. StimSite provides surgeons with an elegant tool to help rapidly identify the ureter, keep it safe from harm, and promote the progression of a pelvic operation. It should be in the toolbox of every surgeon doing pelvic surgery,” Brian Dunkin, former president of the Society of American Gastrointestinal and Endoscopic Surgeons, said in a news release.
Ureter identification is common in procedures such as hysterectomies, endometriosis ablations and colon resections. It is required in over 3 million operations performed in the U.S. every year, according to Allotrope Medical.
“With ureter injuries being top of mind for all surgeons operating in the pelvis, we are excited to be able to offer a technology that helps surgeons identify this important structure in a simple and elegant way,” CEO Albert Huang said.