INFINITY Angioplasty Balloon Catheter™ Receives 510(k) Clearance

June 16, 2020

INFINITY ANGIOPLASTY BALLOON CATHETER ™ has been cleared by the FDA for PTA treatment of peripheral arterial disease, in peripheral vasculature including iliac, femoral, popliteal, infra-popliteal arteries and for the treatment of AV dialysis fistulae.

“The INFINITY catheter represents a game-changing innovation in percutaneous angioplasty balloon design and utility,” states founder and vascular surgeon, John Pigott, MD. “A single SKU to treat lesions from 40mm-250mm in length, is adjustable, to the millimeter, in vivo assuring Precision Angioplasty™, while addressing over 95 percent 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 DCB platform of similar design – protected balloon will assure precise delivery of drug to the lesion site.

We would like to thank our key investors: ProMedica Innovations, Northwest Ohio Tech Fund II, and the Global Cardiovascular Innovation Center.


References:

1 Stay in Circulation: Campaign Materials: Facts about Peripheral Arterial Disease (P.A.D.). Nhlbi.nih.gov. https://www.nhlbi.nih.gov/health/educational/pad/materials/pad_extfctsht_general.html. Published 2018. Accessed November 5, 2018.

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