FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

Aziyo’s Bioscaffold Cleared by FDA for Expanded Use

Dec. 3, 2018
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The FDA has granted 510(k) clearance for Aziyo’s CanGaroo envelope, a naturally occurring bioscaffold used to hold cardiac implantable electronic devices (CIEDs).

The bioscaffold conforms to the implantable device to provide a stabilized environment for CIEDs like pacemakers and defibrillators after implantation.

The device can help to improve patient comfort, reduce device migration and make device removal easier for exchanges or revisions.

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