Tuesday, SafeStitch Medical Inc. (SFES.OB) received clearance from the U.S. Food and Drug Administration or FDA to market its AMID Stapler in the U.S. with the intended use in general surgery procedures for fixation of mesh, in the repair of hernia defects and in other surgical specialties for the approximation of tissues, including skin. The AMID Stapler is the first surgical stapler designed specifically for use in inguinal hernia repairs using the Lichtenstein method, in which mesh is implanted to reinforce the groin floor.
The company has also applied for clearance to market the AMID Stapler in the European Economic Community and other areas outside of the U.S. SafeStitch designed the stapler in collaboration with Parviz Amid, an early pioneer and world-renowned teacher of the Lichtenstein repair.
Safestitch Medical Inc., a developmental stage medical device company, focuses on the development and sale of medical devices. The company offers medical devices that manipulate tissues for obesity, gastroesophageal reflux disease, Barrett's esophagus, esophageal obstructions, upper gastrointestinal bleeding, hernia formation, and other intraperitoneal abnormalities through endoscopic and minimally invasive surgery.
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