Olympus America Inc announces that the company has received 510(k) clearance from the US Food and Drug Administration (FDA) for the company’s next-generation laparoscopic PK Morcellator, a system for laparoscopic tissue containment and extraction.
At the AAGL 45th global congress Olympus America Inc announced that the company has received 510(k) clearance from the US Food and Drug Administration (FDA) for the company’s next-generation laparoscopic PK Morcellator, a system for laparoscopic tissue containment and extraction.
Dr Jubilee Brown, Professor, Levine Cancer Institute, Carolinas Health Care System, Charlotte, North Carolina, and Dr Arnold Advincula, Vice-Chair & Chief of Gynecology at Sloane Women’s Hospital, Columbia University Medical Center/New York-Presbyterian Hospital, gave remarks to members of the press at the company’s unveiling of the new system.
The laparoscopic PK Morcellator, which uses energy rather than blades to break up tissue, together with the PneumoLiner, a containment device cleared by the FDA for gynecologic surgery in April 2016, make up the Olympus Contained Tissue Extraction System. Dr Brown’s article “A containment system for morcellation” in the October 2016 issue of Contemporary OB/GYN discusses the PneumoLiner in detail.
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. A strict surgeon training protocol for the system has been validated involving surgeons with varying levels of experience, according to Olympus. 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.
“Contained tissue extraction is continually evolving,” noted Dr Advincula. “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.”