GI Windows Surgical磁性吻合系统获FDA扩大许可，可用于胃与小肠连接手术
医疗科技公司 GI Windows Surgical 10月29日在 Canton, Massachusetts 宣布，其 Flexagon Plus OTOLoc 系统获得美国食品药品监管局（FDA）扩大适应症许可，可用于胃部连接手术，涵盖胃与小肠之间的连接，包括胃空肠吻合术（GJ）。
胃空肠吻合是胃肠外科中技术要求高、临床影响大的一步。公司表示，其平台是目前全球唯一一种能在吻合建立时即形成即时管腔的磁性吻合技术；而现有标准治疗要求吻合在建立时即保持管腔通畅。这一能力使外科医生可以在 Roux-en-Y 胃旁路等标准术式中使用磁性压缩吻合。
首席执行官 Brian Tinkham 表示，胃部许可是 GI Windows Surgical 的一个决定性里程碑，也是其平台的重要进展，公司正把磁性吻合带到一个效率、一致性与愈合质量都具有深远临床意义的连接部位。首席医疗官 Erik B. Wilson 博士表示，胃空肠吻合是吻合质量至关重要的连接，公司一项多中心、85名患者的试验是推进这项技术的重要临床工作，公司希望借此把吻合建立标准化、支持可靠愈合，并有望减少与胃空肠吻合相关的并发症。
GI Windows Surgical 是一家处于商业化阶段的医疗科技公司，总部位于 Canton，专注推进用于胃肠外科的磁性压缩吻合技术；其 Flexagon Plus OTOLoc 平台把自成型磁体与即时管腔技术结合，公司目标是提升手术效率、推动标准化并改善患者结局。
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.
来源：GSM·美国（原文链接）
图片来源：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.
