INFINITY Angioplasty Balloon Catheter™ Receives 510(k) Clearance

TOLEDO, Ohio, June 16, 2020 /PRNewswire/ -- INFINITY ANGIOPLASTY BALLOON CO. announced today that its innovative balloon platform – 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 – 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 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. 

About Peripheral Arterial Disease
Peripheral Arterial Disease (PAD) is a narrowing of the peripheral arteries caused by plaque and fat deposits in the arteries. More than 12 million people in the US and 30 million people worldwide are affected by PAD which most commonly affects the arteries of the pelvis and legs, including the femoral and popliteal arteries. Left untreated, patients with PAD are five times more at risk for limb amputation.¹

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.

About INFINITY Angioplasty Balloon Co., LLC.
IABC, LLC develops and markets innovative endovascular medical devices for the treatment of peripheral and coronary disease. Founded by vascular surgeon, John Pigott, MD, the Company is based in the ProMedica Innovations Center and member of BioOhio.  For more information, contact the Company.

About ProMedica Innovations
ProMedica Innovations is a non-profit, mission-driven, community-based, nationally recognized center based in Toledo, Ohio. With the goal of helping local inventors, employees and community members develop and commercialize intellectual property around healthcare, all to improve patient healthcare and therefore improve outcomes in people's lives.  The ProMedica Innovations Center is a world-class facility with a dedicated staff to help be the landing point and launch pad for some of the technologies being commercialized. ProMedica Innovations seeks to stimulate the establishment and growth of medical device and bio-informatics start-up companies and to increase the number of successful companies originating and further developing ProMedica communities. By fulfilling this mission, it contributes to job creation and enhanced economic health in the region.

SOURCE INFINITY Angioplasty Balloon Company