Medtronic Gets OK to Start Drug-Coated Balloon Trial

Medtronic said on Thursday it received an investigational device exemption from the US Food and Drug Administration (FDA), which now enables it to begin a study of the IN.PACT Admiral drug-coated balloon (DCB) for a potential new indication in patients with end-stage renal disease.

The exemption approval enables Medtronic to initiate the study and gain safety and effectiveness data for the device in this investigational indication, it said.

The company said separately that he US Centers for Medicare and Medicaid Services (CMS) made a decision to cover the first and only leadless pacemaker available in the US under its final National Coverage Determination.

This decision will provide Medicare patient access to leadless pacemakers, consistent with the FDA-approved labeling for the devices, through Medicare`s policy of Coverage with Evidence Development, the company said.

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