Laparoscopic Power Morcellator Now Available with Contained Tissue Extraction System
Blue Endo is pleased to announce the market launch of the Contained Tissue Extraction System, comprised of the MOREsolution™ Power Morcellator manufactured by TROKAMED GmbH, and the 2021 510(k)-cleared containment device for use during power morcellation, the More-Cell-System manufactured by Agency for Medical Innovations.
Current guidance from the U.S. Food & Drug Administration states that laparoscopic power morcellation for myomectomy or hysterectomy should be performed only with a compatible tissue containment system, legally marketed in the United States for use during laparoscopic power morcellation, and performing these procedures only in appropriately selected patients1.
The More-Cell-System is intended for use as a tissue containment system during minimally invasive gynecologic laproscopic surgery, with the objective of isolating small pieces of tissue, cell particles and fluids, resulting from morcellation, in a closed, tissue containment system.
Contained tissue extraction is not indicated for use with tissue that is known or suspected to contain malignancy. Laproscopic power morcellation should not be used for removal of uterine tissue containing suspected fibroids in patients who are peri- or post-menopausal or over 50 years of age or who are candidates for en bloc tissue removal vaginally or via a mini-laparotomy incision. The risk of occult cancer, including uterine sarcoma, increases with age, particularly over 50 years of age. Uncontained power morcellation has been associated with the spread of benign uterine tissue, potentially requiring additional surgeries.
WARNING: Information regarding the potential risks of a procedure with this device should be shared with patients. Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients. The use of this containment system has not been clinically demonstrated to reduce this risk.
For more information, please read the full MOREsolution™ and More-Cell-System Instructions for Use for indications, additional contraindications, warnings and precautions.
1UPDATE: Perform Only Contained Morcellation When Laparoscopic Power Morcellation Is Appropriate: FDA Safety Communication. FDA.gov. Published December 29, 2020. Accessed February 1, 2023. https://www.fda.gov/medical-devices/safety-communications/update-perform-only-contained-morcellation-when-laparoscopic-power-morcellation-appropriate-fda