The multi-functional device enables both cutting and coagulation via flexible endoscopy and is now cleared for US clinical use.
Creo Medical has received clearance from the US Food and Drug Administration (FDA) for its SpydrBlade Flex device, completing the company’s regulatory approvals for its suite of advanced energy gastrointestinal (GI) tools.
SpydrBlade Flex is a multi-modal endoscopic device that provides both cutting and coagulation functions—features traditionally found in laparoscopic surgery—via a flexible endoscope. It is designed for a range of therapeutic endoscopy procedures and combines multiple functionalities in a single tool.
Following its commercial launch in Europe in March 2025, SpydrBlade Flex has been used in procedures including:
- Zenker’s Peroral Endoscopic Myotomy
- Colonic ESD
- Oesophageal ESD
- POEM
- F-POEM
With FDA clearance secured, Creo plans to begin commercial rollout in the United States through its direct sales force and clinical partnerships.
The clearance comes shortly after the American Medical Association’s May 2025 decision to introduce reimbursement codes for endoscopic submucosal dissection, establishing a reimbursement pathway that may support broader adoption of tools like SpydrBlade Flex.
The device is part of Creo’s lineup of advanced energy GI products, which also includes Speedboat UltraSlim, Speedboat Notch, and MicroBlate Fine.
“FDA clearance for SpydrBladeTM Flex confirms the strength and novelty of our GI product portfolio. The device has overcome significant design challenges, with unique intellectual property that sets it apart in the market,” says Craig Gulliford, chief executive officer of Creo Medical, in a press release.
Photo caption: SpyderBlade Flex
Photo credit: Creo Medical
