FDA Clearance to Market the AMID Stapler

510(k) clearance from the U.S. Food and Drug Administration has been given to SafeStitch Medical, Inc. 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 Dr. Parviz Amid, an early pioneer and world-renowned teacher of the Lichtenstein repair. Dr. Charles J. Filipi, SafeStitch’s medical director and former president of the American Hernia Society, notes that “approximately one million hernia repairs are performed in the U.S. each year, and the Lichtenstein repair is used in 60% to 70% of inguinal hernia repairs worldwide. Based on our preliminary clinical experience, we believe the AMID StaplerTM will make the Lichtenstein repair faster and will be especially attractive to surgeons presently affixing mesh and closing incisions with sutures.”

“The AMID Stapler has an angled staple delivery for safety and better visibility, patented mesh manipulators for easy and safe mesh placement, and has 17 box–shaped, sharp-tipped titanium staples designed specifically for this repair,” explains Dr. Stewart Davis, SafeStitch’s COO. Dr. Davis adds that “although the AMID StaplerTM was designed for inguinal hernia repairs, it is versatile and can also be used to perform ventral hernia repairs and to close skin for either type of repair.”

Jeffrey Spragens, SafeStitch’s President and CEO, notes that “this FDA clearance marks the completion of the development phase for SafeStitch’s first four products: the SMART Dilator, Standard BiteBlock, Airway BiteBlock and the AMID Stapler. We will now begin our commercialization efforts for these products, starting with the launch of the AMID Stapler. Our product development efforts are now fully focused on SafeStitch’s minimally invasive gastroplasty devices for obesity and GERD procedures. We have successfully completed our pre-clinical laboratory studies with these devices, and we are preparing IDE applications for FDA clearance to conduct multicenter clinical trials.”