INFINITY Angioplasty Balloon Catheter™ Receives 510(k) Clearance: Game Changing Innovation in Percutaneous Angioplasty Balloon Design and Utility

CathWorks FFRangio™ System Receives National Reimbursement Approval in Japan

CathWorks announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the application to provide reimbursement for the CathWorks FFRangio™ System,...

Levine Leichtman Capital Partners Sells FlexXray

Levine Leichtman Capital Partners ("LLCP"), a Los Angeles-based private equity firm, announced today that it has sold its portfolio company FlexXray Holdings, LLC ("FlexXray" or...

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 – 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 a similar design – protected balloon will assure precise delivery of drug to the lesion site.

Key investors include ProMedica Innovations, Northwest Ohio Tech Fund II, and the Global Cardiovascular Innovation Center.

spot_img

DON'T MISS

Asensus Surgical Appoints Two New Board Members

Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today announced the expansion of its Board of Directors, appointing...

Our Sister Publication: Biotechnology News Magazine

Subscribe to Medical Device News Magazine here.