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www.fdanews.com/articles/173528-medtronic-receives-fda-clearance-for-tyrx-neuro-absorbable-antibacterial-envelope
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Medtronic Receives FDA Clearance for TYRX Neuro Absorbable Antibacterial Envelope

October 9, 2015

Irish Devicemaker Medtronic has received FDA clearance for its TYRX absorbable antibacterial envelope for use with implantable neurostimulators.

The product — a mesh envelope that stabilizes a device after implantation — is available across the U.S. for use with all Medtronic deep brain stimulation systems, the company said.

Medtronic also plans to make the envelope available as an option with implantable neurostimulators to treat chronic pain and bladder and bowel control disorders.

The first implants of the envelope were recently performed at the Barrow Neurological Institute in Phoenix, Ariz. — Michael Cipriano