EndoClot SIA is the first starch-derived submucosal injection system cleared in the U.S. market for endoscopic removal of polyps, adenomas, early stage cancers and other gastrointestinal mucosal lesions
The US FDA’s Center for Drug Evaluation and Research (Credit: The U.S. Food and Drug Administration)
EndoClot Plus (EPI), a privately held medical device company announced the FDA 510(k) clearance of EndoClot Submucosal Injection Agent (EndoClot® SIA) manufactured by EndoClot Plus Co., Ltd. located in Suzhou, China.
This product is expected to be commercially available in the United States beginning in May 2020 and later this year in several international markets.
EndoClot® SIA is the first starch-derived submucosal injection system cleared in the U.S. market for endoscopic removal of polyps, adenomas, early stage cancers and other gastrointestinal mucosal lesions. Starch based polysaccharide has a long history of clinical applications with an excellent safety profile. A specially designed spiral injection syringe is included in the single-use kit for ease of delivering the solution.
“EndoClot® SIA enables longer lasting and higher mucosal elevation with clearer margins than saline and therefore enables more precise and effective removal of the lesion,” said Steve Heniges, President of EPI. “It also increases the safety cushion by creating a greater margin between the mucosa to be resected and the muscle layer to be protected due to the viscosity of the solution. This is very important as it reduces complications and enables the Gastroenterologist to remove the lesions efficiently.”
EPI will utilize its established distribution network along with new strategic partners to bring this innovative product to the GI Endoscopy market.
EndoClot Plus is focused on utilizing its polymer expertise to develop customized medical devices to meet GI clinical needs. With its innovative technology platforms EndoClot Plus aims to become the leading company in creating new biomaterial therapeutic solutions for GI Endoscopy.
EndoClot Plus, Inc. (EPI) is a privately owned company with headquarters in Santa Clara, California. In collaboration with surgeons and biomaterial scientists, EPI developed a breakthrough technology to control bleeding in the gastrointestinal tract by spraying a unique and proprietary powder directly on the wound.
Source: Company Press Release