Medical device manufacturer Creo Medical has obtained FDA approval for their flexible SpydrBlade product.
In a significant development for the medical industry, Creo Medical has secured U.S. Food and Drug Administration (FDA) clearance for its innovative device, the SpydrBlade Flex. This advanced energy GI product is poised to transform the way gastrointestinal procedures are performed, thanks to its flexibility, precision, and multi-functionality.
SpydrBlade Flex, a novel addition to Creo Medical's growing family of products, integrates the harmonic scalpel's precision at the end of a flexible scope. The device has demonstrated clinical versatility in procedures such as Z-POEMs, Colonic ESDOesophageal ESD, POEM, and F-POEM, making it a versatile tool for clinicians.
The FDA clearance confirms the strength and novelty of Creo Medical's GI product portfolio, marking a significant milestone in the company's history. The timing of the clearance aligns closely with the American Medical Association's decision to introduce reimbursement codes for endoscopic submucosal dissection, creating a clear reimbursement pathway for healthcare providers.
SpydrBlade Flex's key features include advanced energy technology for precise tissue interaction, a flexible design for improved maneuverability, and U.S. FDA clearance, indicating it meets safety and efficacy standards for use in the U.S. market. The benefits of this device are expected to include enhanced precision and safety, better access to difficult-to-reach areas, and potentially reduced recovery times compared to more invasive procedures.
Compared to traditional laparoscopic surgery, SpydrBlade Flex offers advantages in reach and precision due to its flexible design. While both methods are minimally invasive, the SpydrBlade may provide superior precision and access to complex anatomy, potentially reducing the risk of complications.
Creo Medical is excited about bringing SpydrBlade Flex to clinicians and patients across the United States, utilising their established direct sales force and strong network of key opinion leaders. The company is proud of this achievement, with Chief Executive Officer Craig Gulliford expressing his pride about the FDA clearance for SpydrBlade Flex.
With unique intellectual property that sets it apart in the market, SpydrBlade Flex is a multi-modal endoscopic device that delivers both cutting and coagulation functions. The goal of SpydrBlade Flex is to bring operating room capability into flexible endoscopy, supporting a broad spectrum of therapeutic endoscopy procedures. Creo will initiate the U.S. commercial rollout of SpydrBlade Flex, further cementing its position as a leader in innovative medical devices.
- Creo Medical's new device, SpydrBlade Flex, employs advanced energy technology and is flexible, providing improved maneuverability in gastrointestinal procedures, including Z-POEMs, Colonic ESDOesophageal ESD, POEM, and F-POEM.
- The U.S. Food and Drug Administration (FDA) clearance for SpydrBlade Flex signifies the device's compliance with safety and efficacy standards, opening up new opportunities in health-and-wellness for both clinicians and patients.
- The timely FDA clearance coincides with the American Medical Association's decision to introduce reimbursement codes for endoscopic submucosal dissection, thereby creating a clear financial pathway for healthcare providers.
- In the competitive medical-devices market, SpydrBlade Flex stands out with its unique intellectual property, offering both cutting and coagulation functions, and aiming to bring operating room capability into flexible endoscopy, contributing to expanded therapies-and-treatments in the field of medical-conditions.
