CENTER VALLEY, Pa., Nov. 16, 2016 /PRNewswire/ -- Olympus America Inc., a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, among other core businesses, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the company's next-generation laparoscopic PK Morcellator, paving the way for a complete solution for laparoscopic tissue containment and extraction. The Olympus Contained Tissue Extraction System comprises the PneumoLiner, a first-of-its-kind containment device cleared by the FDA for gynecologic surgery in April 2016 and the next-generation laparoscopic PK Morcellator to provide certain patients a laparoscopic surgery option to avoid open hysterectomy and myomectomy for uterine fibroid removal. The system was officially introduced November 15 at the American Association of Gynecologic Laparoscopists (AAGL) Annual Meeting. The PneumoLiner containment device and PK Morcellator are not indicated for use in women with tissue that is known or suspected to contain malignancy; and should not be used for removal of uterine tissue containing suspected fibroids in patients who are peri- or post-menopausal, or candidates for en bloc tissue removal vaginally or via mini-laparotomy. Gynecologic professional societies—including the American Congress of Obstetricians and Gynecologists (ACOG), the Society of Gynecologic Oncology (SGO) and AAGL— have openly voiced concerns about exposing the majority of women who have benign fibroids disease to the risk of complications associated with open procedures. 1 The gynecologic professional societies have indicated that morcellation should not be entirely removed as a treatment method and that contained tissue extraction may be a solution. 2 "Contained tissue extraction is continually evolving," noted Arnold P. Advincula, M.D., Vice-Chair & Chief of Gynecology at Sloane Women's Hospital, Columbia University Medical Center/New York-Presbyterian Hospital. "As surgeons, it is our duty to evaluate potential solutions to the surgical challenges we face in clinical practice. We are pleased that Olympus has taken the initiative to develop a unique and well tested system designed specifically to facilitate the option for a laparoscopic approach in women who are at a low risk of having an unexpected malignancy at the time of surgery." Contained Tissue Extraction System Explained The Olympus Contained Tissue Extraction System is the first complete solution designed for contained tissue extraction to enter the US 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.