2015-09-09 11:28:20 UTC

FDA Approves New Submucosal Injection

Sept. 8, 2015

The injectable composition is designed for use during upper and lower endoscopic procedures.

FDA has approved Cosmo Pharmaceuticals’ request for marketing authorization of SIC 8000, an injectable liquid composition for use as a submucosal injection agent.

The injectable composition is used during endoscopic mucosal resection (EMR), endoscopic mucosal dissection (ESD) and polypectomy procedures in the gastrointestinal tract. The device is intended for use in endoscopic procedures in the upper and lower intestinal tract, such as the esophagus, stomach, small intestine, colon, sigmoid colon and rectum, as a submucosal injectable agent during the removal of polyps, adenomas, early stage cancers and other pathological lesions by EMR, ESD or polypectomy.

SIC is injected through a standard commercially available endoscopic injection needle, which is inserted into the working channel of the endoscope. The agent, when injected, creates a cushion in situ by lifting the gastrointestinal mucosa from the submucosal layer, allowing the endoscopist to perform an easy and safe resection procedure. 

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