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FDA approves AirSeal System for transanal endoscopic surgery

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The FDA has granted 510(k) clearance to the AirSeal System for transanal endoscopic surgery, according to a press release from the manufacturer.

“The AirSeal Platform is a key factor in performing an ideal [transanal total mesorectal excision] procedure,” said Joep Knol, MD, a colorectal surgeon from Belgium and, according to the release, the first to use the AirSeal System for transanal surgery. “By achieving a stable pneumorectum and providing optimal smoke evacuation, a meticulous dissection is possible.”

The AirSeal System (SurgiQuest) improves the endoscopic environment by providing stable insufflation of the rectum and continuous smoke evacuation, which has been one of the technological limitations of transanal endoscopic surgery, the release said. The platform differs from conventional insufflation and trocar systems by allowing stable pneumoperitoneum and continuously expelling smoke and plume when energized medical devices like electrocautery, laser or ultrasound are used. It also enables valve-free access to the operative cavity during robotic, laparoscopic and other endoscopic surgical procedures, according to the release.

Transanal endoscopic surgery includes transanal minimally invasive surgery (TAMIS) and transanal total mesorectal excision (TaTME), which has been shown to significantly improve colorectal cancer procedure outcomes.

“The AirSeal System has had a significant impact on our ability to perform both TAMIS and TaTME procedures,” Matthew Albert, MD, program director of the Colorectal Fellowship at Florida Hospital in Orlando and, according to the release, an American pioneer in transanal endoscopic surgery, said in the release. “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,” Roel Hompes, MD, a leading colorectal surgeon at Oxford University Hospitals, NHS Trust, in the United Kingdom, said in the release. “It has enabled us to perform our TaTME procedures in a safe and more effective way.”

Disclosures: Albert’s, Hompes’ and Knol’s relevant financial disclosures are unknown at this time.