Medical device earns FDA 510(k) clearance

Milford, Connecticut – Officials from SurgiQuest Inc. a provider of innovative access technologies for minimally invasive surgery (MIS), announced that its AirSeal System recently received 510(k) clearance from the FDA for Transanal Endoscopic Surgery (TES).

To date, the growth of transanal endoscopic surgery has been limited due to the technological constraints of conventional insufflation technology, which is unable to provide a consistent, smoke-free working space. Because the AirSeal System ensures stable insufflation of the rectum and provides continuous smoke evacuation, surgeons can now perform TES with increased confidence, thus enabling faster adoption and proliferation within the global colorectal community. The category of transanal endoscopic surgery includes both transanal minimally invasive surgery (TAMIS) and transanal total mesorectal excision (TaTME), a surgical technique that has been shown to significantly improve patient outcomes in colorectal cancer procedures.

"The AirSeal Platform is a key factor in performing an ideal TaTME procedure," said Dr. Joep Knol, a colorectal surgeon in Belgium and the first to use the AirSeal System in a transanal surgical approach. "By achieving a stable pneumorectum and providing optimal smoke evacuation, a meticulous dissection is possible."

"The AirSeal System has had a significant impact on our ability to perform both TAMIS and TaTME procedures," stated Matthew Albert, MD, who is the Program Director of the Colorectal Fellowship at Florida Hospital in Orlando, FL and an American pioneer in transanal endoscopic surgery. "From the first time I used it clinically, I knew this technology would elevate our surgical capabilities, improve patient outcomes, and help reduce procedure time and costs."

"Using AirSeal is essential to establish a clear and stable operative field," said Roel Hompes, MD, a leading colorectal surgeon at Oxford University Hospitals, NHS Trust, in the United Kingdom. "It has enabled us to perform our TaTME procedures in a safe and more effective way."

Source: SurgiQuest