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U.S. FDA approved IN.PACT AV paclitaxel-coated balloon for the treatment of Arteriovenous Fistula Lesions

Nov. 21, 2019: Medtronic  announced U.S. Food and Drug Administration (FDA) approval of the IN.PACT™ AV drug (paclitaxel)-coated balloon for the treatment of failing arteriovenous (AV) access in patients with end-stage renal disease (ESRD) undergoing dialysis. vessel restenosis limits the ability to use AV fistulae effectively.

Patients often undergo one to three maintenance procedures per year which can result in significant disruptions to critical hemodialysis care and increased costs to the healthcare system,so in order to minimize the the cost and maximizing a patient’s uninterrupted access to lifesaving dialysis care, Pivotal randomized trial results from the IN.PACT AV Access trial have shown IN.PACT AV DCB can extend the time between reinterventions by maintaining AV access site patency.

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IN.PACT AV DCB, holds the technology from Medtronic’s IN.PACT™ Admiral™ platform, increases blood flow and reduces thickening of the vessel wall by delivering the proven anti-proliferative drug paclitaxel (penetrates deep into the vessel wall to prevent restenosis and  extend time between reinterventions).


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