The US Food and Drug Administration (FDA) has cleared INFINITY Angioplasty Balloon’s new balloon platform INFINITY Angioplasty Balloon Catheter for percutaneous transluminal angioplasty (PTA) treatment of peripheral arterial disease (PAD).
It has also been cleared for use in peripheral vasculature such as iliac, femoral, popliteal, infra-popliteal arteries and for the treatment of AV dialysis fistulae.
PAD is a narrowing of the peripheral arteries due to the plaque and fat deposits in the arteries.
Over 30 million people globally and 12 million people in the US are said to be affected by the condition. Patients with PAD are considered five times more at risk for limb amputation if left untreated.
INFINITY Angioplasty Balloon founder and vascular surgeon John Pigott said: “The INFINITY catheter represents game-changing innovation in percutaneous angioplasty balloon design and utility.
“A single SKU to treat lesions from 40mm-250mm in length is adjustable to the millimetre, in vivo assuring precision angioplasty while addressing over 95% of real-life clinical cases.”
INFINITY Angioplasty Balloon CEO Gary Smith said: “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.”
The company is initially launching an uncoated angioplasty balloon and has plans to launch a Drug-Coated Balloon (DCB) platform of similar design soon.
The protected balloon will assure precise delivery of the drug to the lesion site.