European regulators have issued the CE Mark of approval to AMID Hernia Stapler, a product of Miami based SafeStitch Medical. The stapler, designed for hernia mesh fixation and skin closure, has been 510(k)’ed by the US Food and Drug Administration in November 2009.
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SafeStitch designed the stapler in collaboration with Dr. Parviz Amid, a pioneer of and renowned expert in the Lichtenstein repair. Dr. Charles J. Filipi, SafeStitch’s Medical Director and former President of the American Hernia Society, noted that "approximately one million hernia repairs are performed in the U.S. each year and the Lichtenstein repair is used in as many as 70% of inguinal hernia repairs worldwide. Based on clinical experience to date, we believe the AMID Stapler™ will make the Lichtenstein repair faster and more attractive to surgeons presently affixing mesh and closing incisions with sutures."
"The AMID Stapler™ is angled for safety and better visibility and its patented mesh manipulators permit easy and safe mesh placement. Its 17 box-shaped, sharp-tipped titanium staples are designed specifically for this repair," explained Dr. Stewart Davis, SafeStitch’s COO.