The FDA has given the go-ahead for Advanced Surgical Concepts to market PneumoLiner, the first containment system for use in conjunction with laparoscopic power morcellators to isolate uterine tissue that is not suspected to contain cancer.
PneumoLiner includes a containment bag and a plunger to deliver the device into the abdominal cavity. The tissue slated for removal is then placed in the bag, which is sealed and inflated. The device has been tested in laboratory settings and found to withstand forces in excess of what can expected during a surgical procedure.
Morcellators have received intense media scrutiny after the FDA issued a safety alert in 2014 saying the instrument’s blades could spread unsuspected cancers in as many as one in 352 cases. Because of potential risks, the FDA is requiring the Ireland-based manufacturer to warn patients and healthcare providers that PneumoLiner has not been proven to reduce the risk of spreading cancer during these procedures.
William Maisel, deputy director for science and chief scientist at CDRH, said the device is intended for a limited patient population that has been appropriately informed of the risks of power morcellation.
The device was reviewed through the de novo classification process. — Elizabeth Hollis