Medtronic Drug-Coated Balloon Gets FDA Approval to Treat Arteriovenous Fistula Lesions
November 21 2019 - 11:53AM
Dow Jones News
By Michael Dabaie
Medtronic PLC (MDT) said the U.S. Food and Drug Administration
approved a drug-coated balloon to treat arteriovenous fistula
lesions.
Medtronic said the FDA approved the IN.PACT AV drug-coated
balloon, a paclitaxel-coated balloon indicated to treat failing
arteriovenous access in patients with end-stage renal disease
undergoing dialysis.
The FDA approval is based on data from an investigational device
exemption study, which enrolled 330 subjects, and evaluated the
safety and effectiveness of the IN.PACT AV DCB at 29 sites in the
U.S., Japan, and New Zealand, the company said.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
November 21, 2019 11:38 ET (16:38 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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