The company announced today that it has received CE Mark authorization to commercialize its AMID Stapler in the European Economic Community. The AMID Stapler is the first surgical stapler designed specifically for use in inguinal hernia 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 (FDA) for sale of the AMID Stapler in the United States.
SafeStitch designed the stapler in collaboration with Dr. Parviz Amid, a pioneer of and renowned expert in the Lichtenstein repair. The AMID Stapler is angled for safety and better visibility and its patented mesh manipulators permit easy and safe mesh placement. Its titanium staples are designed specifically for this repair.
There will be a large market for SafeStitch’s new stapler, the company’s first product that the company is commercializing. In the United States alone each year, there are about one million hernia repairs and the Lichtenstein repair is used in as many as 70% of inguinal hernia repairs worldwide.
The CE Mark and FDA clearance marked the completion of the development phase for SafeStitch’s first four products: the SMART Dilator, Standard BiteBlock, Airway BiteBlock and, of course, the AMID Stapler. The company will continue the commercialization efforts for these products, starting with the launch of the AMID Stapler. In addition, the company continues to work on new products.