November 17, 2020
INFINITY Angioplasty Balloon announced today that its innovative PRECISION ANGIOPLASTY™ balloon platform – INFINITY ANGIOPLASTY BALLOON CATHETER™ has successfully completed a First-in-Human clinical trial. Recently cleared by the FDA for PTA treatment of peripheral artery disease including:
- iliac
- femoral
- popliteal
- infra-popliteal arteries
- for the treatment of AV dialysis access
“The INFINITY catheter represents a game-changing innovation in percutaneous angioplasty balloon design and utility,” states founder and vascular surgeon, John Pigott, MD.
John A. Phillips, MD, FSCAI, an interventional cardiologist at OhioHealth Riverside Methodist, 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 Dr. Phillips. “The patient was a 60-year-old woman with highly angulated aortic bifurcation and a 78mm CTO in the distal SFA.”
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 SKU’s 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 DCB platform of similar design that will assure precise delivery of a drug to the lesion site and minimize downstream and systematic effects.
Key investors: JobsOhio, ProMedica Innovations, Northwest Ohio Tech Fund II, and the Global Cardiovascular Innovation Center. Received 510(K). View here.