The Infinity Angioplasty Balloon Company announced today that its angioplasty balloon platform—the Infinity angioplasty balloon catheter—has successfully completed a first-in-human clinical trial.
The platform was recently cleared by the US Food and Drug Administration (FDA) for percutaneous transluminal angioplasty (PTA) 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.
John A Phillips, an interventional cardiologist at OhioHealth Riverside Methodist in Columbus, USA, performed the first-in-human Infinity procedure. “I am extremely pleased with the catheter delivery and to-the-mm sizing of the balloon length to the lesion, particularly in this very challenging case,” commented Phillips. “The patient was a 60-year-old woman with highly angulated aortic bifurcation and a 78mm chronic total occlusion in the distal superficial femoral artery.”
According to a press release, the Infinity platform is the first and only therapy to provide Precision Angioplasty, to-the-mm sizing of balloon length to the lesion. Adopting the platform significantly reduces inventory needs and costs from dozens of stock keeping units and it reduces shelf space requirements, inventory management time, and trunk stock; while delivering the assurance that the right balloon size will always be on the shelf.
“Infinity is a highly differentiated product,” reports CEO Gary Smith. “This is an ideal product for both office-based labs and hospitals.” While initially launching the Infinity angioplasty balloon catheter, the company intends to follow quickly with the Infinity Defender, a drug-coated balloon (DCB) platform of similar design that will assure precise delivery of drug to the lesion site and minimise downstream and systematic effects.