Olympus Contained Tissue Extraction System.
The Olympus Contained Tissue Extraction System is the first complete solution designed for contained tissue extraction to enter the U.S. market, enabling surgeons to isolate and perform uterine tissue morcellation and extraction using the PneumoLiner containment device. The PneumoLiner is currently the first and only containment device to receive FDA market approval for use with certain laparoscopic power morcellators to isolate uterine tissue that is not suspected to contain cancer. Once insufflated, the PneumoLiner allows space and vision throughout the power morcellation procedure while maintaining a barrier to the escape of fluids, cells, and tissue fragments. When insufflated, the PneumoLiner creates a barrier between the targeted tissue and non-targeted abdominal contents, to minimize the risk of inadvertent damage to adjacent structures. Used as directed, the PneumoLiner significantly reduces the risk of disseminating cells and tissue into the peritoneal cavity during power morcellation. A strict surgeon training protocol is required and has been validated involving surgeons with varying levels of experience. Testing conducted with the surgeon training protocol revealed there was no damage to any of the specimen containment bags utilized during this process. Consistent with the FDA's mandate, surgeons who wish to use the containment system will be required to complete a formal training protocol before use.