Meril Endo Surgery received FDA (United States Food and Drug Administration) approval for their Mirus Circular Stapler on February 5, 2021
The Mirus Circular Stapler is similar to existing implantable stapler devices used to create stapled gastrointestinal anastomoses and comes pre-loaded with staples for single-use application. The device simultaneously cuts and applies staples in a circular pattern. The device delivers double staggered concentric rows of staples on the outside of the cut line. The circular stapler is available in diameter of the staple line from 24mm, 25mm, 26mm, 29mm, 32mm or 34mm stapler. The device has a detachable anvil that allows the surgeon to place the anvil in the desired location.
The device was subjected to performance tests including staple height and formation accuracy, pressure resistance and force needed to fire the device, biocompatibility including in vitro, skin, intracutaneous, intramuscular, subchronic systemic toxicity, hemolysis and genotoxicty testing and Ethylene Oxide sterilization validation.
The FDA determined this device to be substantially equivalent to a predicate device (Single Use Circular Stapler, Golden Stapler Surgical Company, Ltd.)
The device is FDA approved for use throughout the alimentary tract for end to end, end to side and side to side anastomoses.
No specific contraindications for use are listed by the FDA.
