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Devices Surgery FDA

 News Release - November 17, 2020

Allotrope Medical Announces FDA Clearance of StimSite(TM)

HOUSTON, Nov. 17, 2020 -- (Healthcare Sales & Marketing Network) -- Allotrope Medical™ Inc., a company committed to advancing surgical safety and precision, today announced its FDA clearance of their device, StimSite. StimSite provides ob/gyns, general and colorectal surgeons the new ability to use their existing surgical instruments to help locate and identify ureters using electrical stimulation. Ureter identification is a critical step in safely advancing in operations such as hysterectomies and colon.

"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," commented Brian Dunkin MD, past president of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES).

Alan Greenberg MD in Frisco, Texas was the first physician to use StimSite during both laparoscopic and robotic gynecologic procedures. He noted, "StimSite is extremely helpful when trying to find the Ureter, and enables the surgeon to save valuable operating time while making the surgery more efficient and safe."

"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," said Albert Huang MD, Allotrope Medical's Chief Executive Officer and the inventor of StimSite. "StimSite gives surgeons a new capability to their existing instruments; helping them to provide the best surgical experience for physician and patient alike."

About Ureter Identification During Surgery

Ureter identification is required in over 3 million operations performed every year in the U.S. These include common procedures such as hysterectomies, endometriosis ablations, and colon resections among others. Injury to ureters can have a significant impact on the patient's hospitalization and overall quality of life. As a result, identification and protection of the ureters during an operation is paramount for all surgeons operating in the pelvis.

About StimSite

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. Intuitive and easy to use, the device provides surgeons with the ability to elicit visible ureteral movement on demand. This is especially beneficial for surgeons operating in the lower abdomen and pelvis. It has an added advantage of seamless workflow integration by connecting with existing laparoscopic and robotic instruments, as well as electrosurgical generators.

ABOUT ALLOTROPE MEDICAL, INC.

Allotrope Medical is committed to helping surgeons safely and easily identify the ureter during pelvic operations. The Houston-based company's first product – StimSite – is designed to assist surgeons in the critical step of ureter identification in millions of operations performed every year. For more information, please visit www.allotropemed.com

StimSite is only available in the United States


Source: Allotrope Medical

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



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