Olympus America has secured FDA 510(k) clearance for its next-generation laparoscopic PK morcellator with tissue containment designed as a laparoscopic surgery option to prevent open hysterectomy and myomectomy for uterine fibroid removal.
The Contained Tissue Extraction System includes PneumoLiner device that is approved by the US Food and Drug Administration (FDA) for gynecologic surgery in April this year.
It will allow surgeons to isolate and carry out uterine tissue morcellation and extraction using the PneumoLiner containment device.
PneumoLiner can be used with certain laparoscopic power morcellators to isolate uterine tissue that is not suspected to contain cancer.
Once treated, PneumoLiner allows space and vision across the power morcellation procedure while maintaining a barrier to the escape of fluids, cells and tissue fragments.
According to the company, additional testing was carried out using the PK Morcellator in combination with the PneumoLiner to show compatibility of the two devices when used together to support the FDA's 510K clearance of the PK morcellator.
Ireland’s Advanced Surgical Concepts manufactures PneumoLine, and is exclusively distributed by Olympus America as part of the Contained tissue extraction system.
Olympus Medical Systems Group president Todd Usen said: "The Olympus Contained Tissue Extraction System provides gynecologists and their appropriate, low-risk patients with what they want again: a choice.
"The Olympus Contained Tissue Extraction System is the solution that will allow gynecologists to once again safely and effectively offer minimally invasive hysterectomies and myomectomies as options to certain low-risk patients."
The company is showcasing the new system at the American Association of Gynecologic Laparoscopists (AAGL) Annual Meeting in Orlando of Florida, which is being held from 14 to 18 November.
Image: The Olympus Contained Tissue Extraction System includes PneumoLiner device and next-generation laparoscopic PK Morcellator. Photo: courtesy of Olympus America Inc.