Allotrope Medical announces FDA Safer Technologies Program (STeP) designation for their surgical device StimSite
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."
StimSite is a device intended to provide electrical stimulation to ureter smooth muscle tissue to help locate and identify ureters by testing ureter smooth muscle excitability. Able to be installed in seconds into any operating room, the device provides surgeons with the ability to elicit visible, full-length ureteral movement on demand using their existing laparoscopic and robotic instruments to deliver the stimulation signal. This allows the surgeon to have real-time ureteral awareness at all steps of the operation without changing instruments.
About the FDA Safer Technologies (STeP) Program
The FDA's Safer Technologies Program (STeP) is a voluntary program for certain medical devices and device-led combination of products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics that target an underlying disease or condition associated with morbidities and mortalities less serious than those eligible for the Breakthrough Devices Program. Devices that are eligible for STeP, unlike those that are eligible for the Breakthrough Devices Program, may include devices that are intended to treat or diagnose diseases or conditions that are non-life-threatening or reasonably reversible.
The goal of STeP is to provide patients and healthcare providers with timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency's mission to protect and promote public health.1
About Allotrope Medical Inc.
Allotrope Medical is a Houston-based company committed to helping surgeons increase efficiency and safety in millions of pelvic operations performed every year. Their product, StimSite, is designed to provide surgeons with ureteral awareness at all steps of their operation with seamless workflow and instrument integration. For more information, please visit www.allotropemed.com
StimSite is only available in the United States.
View original content:https://www.prnewswire.com/news-releases/allotrope-medical-announces-fda-safer-technologies-program-step-designation-for-their-surgical-device-stimsite-301669528.html
SOURCE Allotrope Medical Inc