GI Windows Surgical received FDA 510(k) clearance for its Flexagon self-forming magnet technology.
The FDA granted clearance for the Flexagon laparoscopic and endoscopic delivery system. Westwood, Massachusetts-based GI Windows designed its technology to employ magnetic anastomosis to enable less invasive surgery. It aims to develop the first fundamental breakthrough in anastomosis technology in both delivery and tissue fusion.
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According to the company, the FDA clearance enables magnetic compression anastomosis with the self-aligning, sutureless, staple-free technology. Designed to facilitate anastomosis, it leaves behind no foreign material.
The company says clinical evidence continues to support the efficacy of its approach. To date, it reports no leaks, bleeds or obstructions attributed to its surgical, magnet-based technique.
GI Windows Chief Medical Officer Dr. Erik Wilson said in a news release that the technology integrates laparoscopic delivery, advanced robotics and endoscopic delivery to enable better minimally invasive procedures. The company designed Flexagon to reduce operating time, standardize anastomotic techniques and minimize complications.
“FDA clearance of Flexagon marks a pivotal milestone, not just for our company, but for the future of minimally invasive surgery,” said Brian Tinkham, CEO of GI Windows Surgical. “Our team is excited for the next phase of our business.”
This marks more good news for GI Windows, which last fall raised $37 million to support its Flexagon technology.
