Olympus America Inc. introduces the next-generation laparoscopic PK Morcellator, a complete solution for laparoscopic tissue containment and extraction. Next-generation Tissue Extraction System comprises the PneumoLiner, a first-of-its-kind containment device cleared by the FDA for gynecologic surgery in April 2016.
Tissue Extraction System is the first complete solution designed for contained tissue extraction to enter the US market. It enables surgeons to separate and perform uterine tissue morcellation and extraction using the PneumoLinear containment device.
The company also introduces the next generation laparoscopic PK Morcellator to provide patients a laparoscopic surgery option to avoid open hysterectomy and myomectomy for uterine fibroid removal.
In addition, the PneumoLiner containment device and PK Morcellator are not indicated for use in women with tissue that is known or suspected to contain malignancy.
It should not be used for removal of uterine tissue containing alleged fibroids in patients who are peri or post menopausal or candidates for en bloc tissue removal vaginally or via mini laparotomy.
The PneumoLiner can be used with various laparoscopic power morcellators to isolate uterine tissue that is not supposed to contain cancer. The PneumoLiner allows space and vision throughout the power morcellation procedure while maintaining a barrier to the escape of fluids, cells, and tissue fragments.
Filtration and immersion testing was performed which authorized that the PneumoLiner is resistant to human cells and that the containment bag maintains its integrity following morcellation.
The device could withstand forces in excess of those expected to occur in actual use. PneumoLiner provides sufficient visualization and space to carry out morcellation.
PK Morcellator along with the PneumoLiner was used to carry out the additional testing and it will demonstrate compatibility of the two devices when used together to support the FDA’s 510K clearance of the PK Morcellator.
These tests are performed with the surgeon training protocol and the containment system will be required to complete a formal training protocol before use.
The Olympus Contained Tissue Extraction System for removal of uterine tissue in select patients can address key healthcare objectives:
• Increased Quality Care—The use of a laparoscopic surgical approach can increase the quality of patient care, as an open hysterectomy can lead to an increase in major surgical complications (2.2% to 2.8%) with an increase in hospital readmission within 30 days (3.4% to 4.2%)
• Decreased Costs—An increase in quality care leads to a decrease in overall patient costs, as the median episode cost for readmission was noted in one study to be $5,847, with a range of $5,478-$10,389.4 A strategy of minimally invasive laparoscopic hysterectomy is a cost effective surgical method versus an open hysterectomy, $20,853.15 vs. $30,359.92, respectively
• Enhanced Patient Satisfaction—Patients whose surgeons use a minimally invasive surgical approach may experience fewer preoperative complications, shorter hospital stays, less pain, improved quality of life and a faster return to normal activity. A 2016 study by Po et al revealed that 65% of women, after weighing the risks and benefits, would choose a minimally invasive surgical approach if the risk of cancer spreading was calculated at 1 in 350, the estimate the FDA evaluated.