Surgical device for ureter identification granted FDA designation

The US healthtech company Allotrope Medical has received FDA Safer Technologies Program (STeP) designation for its surgical device for ureter identification.

StimSite is the company’s first product which was designed to assist surgeons in the critical step of ureter identification in lower abdominal and pelvic procedures.

The device has been used by surgeons to help locate and identify ureters through electrical stimulation. It can be installed in operating rooms and can help surgeons elicit visible, full-length ureteral movement using their existing laparoscopic and robotic instruments.

Millions of lower abdominal and pelvic procedures are performed every year including hysterectomies, endometriosis excisions and colon resections.

Surgeons across the US started using Allotrope’s technology in 2020 after it was cleared by the FDA and noticed an improvement in their operative experience through rapid ureter verification.

Additionally, they observed an increased predictability and decreased duration of their post-procedure cystoscopies.

“Surgeons are constantly learning new techniques, either robotics or laparoscopic, and safety is always front and centre,” said Dr Craig McCoy, a urogynecologist and one of the technology’s early adopters.

“StimSite allows a surgeon to rapidly verify its identity, create ureteral awareness during the case, and potentially have a substantial impact on shortening cystoscopies at the end of the case.

“All these benefits align with the FDA’s Safer Technologies Program and are well-deserved.”

Dr Richard Farnam, an expert in robotic gynaecologic surgery, added: “StimSite is a game changer. I now have ‘on-demand’ ureter identification with induced vermiculation.

“The technology is seamlessly integrated into my surgical procedure and robotic workflow. How much is your time worth? I use StimSite to facilitate ureter efflux, and have observed a significant reduction in my post-procedure cystoscopy time.”

Dr Albert Huang, founder and CEO of Allotrope Medical, said: “We are both excited and honoured to be part of the FDA’s Safer Technologies Program.

“I created StimSite to advance efficiency and safety for those operating in the pelvis, and these advancements now in the post-procedure cystoscopy space continue to show how we are improving the surgical experience for the OR team, surgeons and most importantly, the patients in a way that no other technology out there is able to.”

The new designation, along with a proposed additional indication for use, reflects StimSite’s value that while performing cystoscopy during open or minimally invasive surgical procedures, the device may decrease the time for functional urodiagnostic tests to confirm intact ureters, the Texas-based company explained.