Creo Medical Secures FDA Clearance for SpydrBlade™ Flex, Advancing U.S. Market Launch
We are pleased to announce that we have received U.S. Food and Drug Administration (FDA) clearance for its SpydrBlade™ Flex device. This clearance marks a significant milestone for Creo, completing FDA approvals for its full suite of advanced energy GI products.
SpydrBlade™ Flex is a novel, multi-modal endoscopic device that delivers both cutting and coagulation functions - traditionally available only in laparoscopic surgery - via a flexible endoscope. Engineered to support a broad spectrum of therapeutic endoscopy procedures, the device integrates precision, adaptability, and multi-functionality - empowering clinicians with a versatile tool that simplifies complex interventions and accelerates adoption in real-world clinical settings.
Following its successful commercial launch in Europe in March 2025, SpydrBlade™ Flex has already demonstrated clinical versatility in procedures such as:
- Z-POEMs (Zenker’s Peroral Endoscopic Myotomy)
- Colonic ESD
- Oesophageal ESD
- POEM
- F-POEM
With FDA clearance secured, Creo will now initiate the U.S. commercial rollout, leveraging its established direct sales force and strong network of key opinion leaders.
Supporting U.S. Market Access
The timing of this clearance aligns closely with the American Medical Association’s May 2025 decision to introduce reimbursement codes for endoscopic submucosal dissection. These developments create a clear reimbursement pathway for healthcare providers, paving the way for adoption of next-generation tools like SpydrBlade™ Flex.
The device joins Creo’s growing family of advanced energy GI products, including:
Craig Gulliford, Chief Executive Officer of Creo, said:
“This is a proud and pivotal moment for Creo. FDA clearance for SpydrBlade™ 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.”
“Professor Robert Hawes MD once described SpydrBlade™ Flex as ‘the harmonic scalpel at the end of a flexible scope,’ which perfectly encapsulates our goal: bringing operating room capability into flexible endoscopy.”
“With a clear path to reimbursement and a ready-to-deploy sales infrastructure, we’re excited about bringing SpydrBlade™ Flex to clinicians and patients across the United States.”
