GI Windows Surgical Wins FDA Clearance to Expand Magnetic Anastomosis System to Gastric Procedures
Medical technology company GI Windows Surgical announced on October 29 in Canton, Massachusetts that the U.S. Food and Drug Administration (FDA) has cleared an expanded gastric indication for its Flexagon Plus OTOLoc System. The clearance extends the platform to connections between the stomach and small intestine, including gastrojejunostomy (GJ).
Creating a gastrojejunostomy is a technically demanding and clinically consequential step in gastrointestinal surgery. The company says its platform is the only magnetic anastomosis technology in the world with an immediate lumen, while the standard of care requires immediate luminal patency at the time an anastomosis is created. That capability lets surgeons use magnetic compression anastomosis in standard procedures such as Roux-en-Y gastric bypass.
Chief Executive Officer Brian Tinkham called the gastric clearance a defining milestone for GI Windows Surgical and an important advancement for its platform, bringing magnetic anastomosis to a connection where efficiency, consistency and healing have profound clinical importance. Chief Medical Officer Erik B. Wilson, MD, said the company is running a multicenter, 85-patient trial as part of the clinical work advancing the technology, with the aim of standardizing anastomosis creation, supporting reliable healing and potentially reducing GJ-related complications.
GI Windows Surgical is a commercial-stage company based in Canton, Massachusetts, advancing magnetic compression anastomosis for gastrointestinal surgery. Its Flexagon Plus OTOLoc platform combines self-forming magnets with immediate-lumen technology, with a focus on procedural efficiency, standardization and patient outcomes.
Source: GSM · USA (original Chinese edition)
Photo: 图：一间现代手术室，外科吻合是胃肠手术的关键步骤（资料图，非涉事器械）。照片：Pfree2014 摄，CC BY-SA 4.0，经 Wikimedia Commons。 / A modern operating room; surgical anastomosis is a key step in gastrointestinal surgery (illustrative photo, not the device in this story). Photo: Pfree2014, CC BY-SA 4.0, via Wikimedia Commons.
