Allotrope Medical Receives STeP Designation from FDA

Home » Blog » Allotrope Medical Receives STeP Designation from FDA

Allotrope Medical‘s surgical device, was recently granted FDA Safer Technologies Program (STeP) designation. This designation highlights the value of their surgical device, StimSite, that helps surgeons locate ureters through electrical stimulation and may increase cystoscopy efficiency.
Read the full story here.

HOUSTON, Nov. 7, 2022 /PRNewswire/ — Allotrope Medical™ Inc., a company committed to advancing surgical efficiency and safety, announced that they have received Safer Technologies Program (STeP) designation from the FDA for their surgical device StimSite. For the past year, StimSite has been used by surgeons to help locate and identify ureters through electrical stimulation. This 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.

With millions of lower abdominal and pelvic procedures performed every year including hysterectomies, endometriosis excisions and colon resections, there is a need for a simple, seamless, cost-effective technology that supports the surgeon and staff with awareness and verification of the ureter during surgery. Since StimSite’s FDA clearance in late 2020, surgeons across the United States have been using the technology to improve their operative experience through rapid ureter verification during all steps of the operation. During use of StimSite, surgeons also 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 center. 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,” commented Dr. Craig McCoy, a well-known urogynecologist and one of the technology’s early adopters.

Dr. Richard Farnam, a world leader in robotic gynecologic 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.”

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