Allotrope Medical Announces FDA Safer Technologies Program (STeP) Designation for its StimSite Surgical Device
HOUSTON, November 7, 2022 /PRNewswire/ — Allotrope Medical™ Inc., a company committed to advancing surgical efficiency and safety, announced that it has received FDA Safer Technologies Program (STeP) designation for its StimSite surgical device. Over the past year, StimSite has been used by surgeons to help locate and identify ureters through electrical stimulation. This designation, along with an additional proposed indication for use, reflects StimSite’s value that when performing cystoscopy during open or minimally invasive surgical procedures, the device can reduce the time required for testing. functional urodiagnostics to confirm intact ureters.
With millions of lower abdominal and pelvic procedures performed each year, including hysterectomies, endometriosis excisions, and colon resections, there is a need for simple, transparent, and cost-effective technology that helps surgeons and staff know and to check the ureter during surgery. Since StimSite’s FDA clearance in late 2020, surgeons across United States used the technology to improve their operative experience with rapid verification of the ureter at all stages of the operation. When using StimSite, surgeons also observed increased predictability and decreased time for their post-operative cystoscopies.
“Surgeons are constantly learning new techniques, robotic or laparoscopic, and safety is always top of mind. StimSite allows a surgeon to quickly verify their identity, create ureteral awareness during the case, and potentially have a substantial impact on the shortening of cystoscopies at the end of the case. All of these benefits align with the FDA’s Safer Technologies program and are well-deserved,” commented Dr. Craig McCoya well-known urogynecologist and an early adopter of the technology.
dr. Richard Farmana world leader in robotic gynecological surgery, added, “Stimsite is a game-changer. I now have on-demand identification of the ureter 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 seen a significant reduction in my post-procedure cystoscopy time.”
“We are both thrilled 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 the efficiency and safety of those operating in the pelvis, and these advances in the field of post-operative cystoscopy continue to show how we are improving the surgical experience for the team of operating room, surgeons and, more importantly, patients in a way that no other technology is able to do.”
StimSite is a device intended to deliver electrical stimulation to ureteral smooth muscle tissue to help locate and identify ureters by testing ureteral smooth muscle excitability. Able to be installed in seconds in any operating room, the device offers surgeons the ability to induce visible full-length ureteral movement on demand using their existing laparoscopic and robotic instruments to deliver the signal. stimulation. This allows the surgeon to have real-time ureteral awareness at all stages 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-driven product combinations that can reasonably be expected to significantly improve the safety of currently available treatments or diagnostics that target an underlying disease or condition associated with less severe morbidity and mortality than those eligible for the Breakthrough Devices program. Devices eligible for the STeP program, unlike those eligible for the Breakthrough Devices program, may include devices intended to treat or diagnose diseases or conditions that are not life-threatening or reasonably reversible.
STeP’s goal is to provide patients and healthcare providers with rapid access to these medical devices by accelerating their development, evaluation and review, while preserving legal standards of pre-market 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.
Medical Allotrope is a Houstonis committed to helping surgeons increase the efficiency and safety of the millions of pelvic surgeries performed each year. Their product, StimSite, is designed to provide surgeons with ureteral awareness at all stages of their operation with seamless workflow and instrument integration. For more information, visit www.allotropemed.com
StimSite is only available in the United States.
SOURCE Allotrope Medical Inc