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(Sharecast News) - Medical devices company Creo Medical Group said on Wednesday that its SpydrBlade Flex device has received US Food & Drug Administration clearance.
Creo's said FDA clearance of SpydrBlade Flex, a multi-modal endoscopic device designed for precision and adaptability in therapeutic endoscopy procedures, allows it to initiate the device's launch in the US market.
The AIM-listed group noted that the existing direct sales force, alongside its established network of key opinion leaders and clinicians, also allows for "rapid adoption" of the SpydrBlade Flex in the "critical" US market.
Creo added that following the commercial launch of the product in Europe, the list of established clinical use-cases was growing and already includes Z-POEMs, pedunculated polyps, general dissections and difficult-to-treat fibrotic cases.
Chief executive Craig Gulliford said: "This is an important commercial milestone for Creo as we have now received FDA clearance for our full suite of advanced energy GI products for resection, dissection and ablation.
"This product has tested us with some of our most difficult design challenges, the novelty of which and the associated IP (intellectual property), alongside our range of GI products, significantly differentiates Creo in the market."
As of 1050 BST, Creo Medical shares were down 1.87% at 15.21p.
Reporting by Iain Gilbert at Sharecast.com
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