FDA’s Approval of the Medtronic Micra AV

When my father had a pacemaker placed, the Micra was not yet launched and he had leads detach two times, requiring additional interventions. The Micra would have been perfect for him.

I wrote about Medtronic’s Micra leadless pacemaker and am thrilled to hear about the Micra AV—a leadless pacemaker on digital health steroids. According to Mass Device[i] the Micra AV has “the same size and shape of the original Micra but includes new internal atrial sensing algorithms.” As per medtech best practices, MDT will launch the Micra AV into a limited number of sites over the next few weeks. A full launch expected in the spring of 2020.

The Micra system is uniquely designed. It is implanted inside the heart’s right ventricle eliminating the need for leads to the heart. The Micra AV will provide dual-chamber pacing systems—a huge advance.

The Micra AV can adjust pacing in the ventricle to restore regular AV synchronous rhythm, to patients with atrioventricular block. These patients are indicated for dual-chamber pacemaker.

This is a powerful new indication expanding the use of the Micra AV to 50% or more of the patient population that needs a pacemaker. The big benefit is a minimally invasive implant procedure (my dad had a lot of pain following his pacemaker implantation). The less invasive the better—you can’t go wrong with that!

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