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Medtronic plc

Medtronic plc

Medical device manufacturer

Appears in 2 stories

Stories

Medtronic wins first FDA approval for a defibrillation lead that paces through the heart's natural wiring

New Capabilities

Manufacturer of the OmniaSecure lead; market leader in cardiac rhythm management

For decades, implantable defibrillators have saved lives by shocking dangerously fast heart rhythms back to normal — but the leads that deliver those shocks also pace the heart in an unnatural pattern that can itself cause damage over time. Medtronic's OmniaSecure lead, now cleared by the Food and Drug Administration (FDA) for placement in the left bundle branch area, is the first defibrillation lead that can also pace through the heart's own electrical wiring, closely mimicking natural heartbeats.

Updated Mar 23

The long road to FDA approval for spinal biologics

New Capabilities

Developer and manufacturer of INFUSE bone graft

For 24 years, Medtronic's INFUSE bone graft has followed a winding path through FDA approval, off-label controversy, lawsuits, and now expansion. The Food and Drug Administration (FDA) just granted INFUSE approval for transforaminal lumbar interbody fusion (TLIF) procedures—making it the only growth factor bone graft approved for two-level spinal constructs and the only one cleared for anterior, oblique, and transforaminal approaches.

Updated Feb 17