SafeStitch Medical, Inc. (OTCBB: SFES) announced today that it has
received CE Mark authorization to commercialize its AMID StaplerTM
in the European Economic Community. The new stapler is to be used for
fixation of mesh in the repair of hernia defects and also 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 for
reinforcement. SafeStitch announced in November 2009 that it had
received 510(k) clearance from the Food and Drug Administration for sale
of the AMID StaplerTM in the U.S. market.
“The AMID StaplerTM 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”
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 StaplerTM
will make the Lichtenstein repair faster and more attractive to surgeons
presently affixing mesh and closing incisions with sutures.”