INFINITY Angioplasty Balloon Catheter receives 510(k) clearance

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The Infinity Angioplasty Balloon Company has announced that its balloon platform—the INFINITY Angioplasty Balloon Catheter—has been cleared by the US Food and Drug Administration (FDA) for percutaneous treatment of peripheral arterial disease.  

“The INFINITY catheter represents a game changing innovation in percutaneous angioplasty balloon design and utility,” states founder and vascular surgeon, John Pigott. “A single SKU to treat lesions from 40–250mm in length, is adjustable, to the millimetre, in vivo assuring Precision Angioplasty, while addressing over 95% of real-life clinical cases.”

“Adopting the INFINITY platform reduces inventory needs and costs from dozens of SKU’s to two, it reduces space requirements, inventory management time, and trunk stock, while delivering the assurance that the right balloon size will always be on the shelf—INFINTY is a highly differentiated product,” reports CEO Gary Smith. “This is an ideal product for both office-based labs and hospitals.”

While initially launching an uncoated angioplasty balloon, the company intends to follow quickly with a drug-coated balloon platform of similar design.


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