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Medical Devices / Submissions and Approvals

FDA Grants Marketing Authorization for Two Catheters

July 3, 2018

The FDA granted marketing authorization for two catheters used to create connections between veins and arteries in patients with chronic kidney disease in need of hemodialysis.

The two devices, Avenu’s Ellipsys vascular access system and TVA Medical’s EverlinQ endoAVF system, allow physicians to create a percutaneous arteriovenous fistula to enable hemodialysis access.

The devices should not be used to create connections in vessels that are less than two millimeters in diameter or too far apart, such as in the wrist or hand, the agency said. Device complications include stenosis or occlusion of the fistula, as well as bruising.

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