Pneumoliner for Contained Tissue Extraction (ROW)
- Pneumoliner is a first-of-its-kind tissue containment device that provides appropriate patients with a laparoscopic surgery option for hysterectomy and myomectomy. Pneumoliner is the first and only device that provides tissue containment during power morcellation.
- Pneumoliner is intended to be ussd as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during single-port or multi-site laparoscopic surgery during power morcellation and removal.
- The PneumoLiner is compatible with bipolar or electromechanical laparoscopic power morcellators that are between 15 mm and 18 mm in shaft outer diameter and 135 mm and 180 mm in shaft working length and which have an external component that allows for the proper orientation of the laparoscope to perform a contained morcellation.
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. The use of this containment system has not been clinically demonstrated to reduce this risk.
CONTRAINDICATIONS
Do not use on tissue that is known or suspected to contain malignancy. Do not use for removal of uterine tissue containing suspected fibroids in patients who are: post-menopausal or over 50 years of age; or candidates for en bloc tissue removal, through the vagina or via a mini-laparotomy incision. Do not use in women with undiagnosed uterine bleeding. Do not use this device on patients with known or suspected allergies to polyurethane. Do not use where the abdominal wall thickness is larger than 10cm. This device should only be used by physicians who have completed the formal validated required training program administered by Olympus and/or Advanced Surgical Concepts