The Micra transcatheter pacing system may be considered medically necessary in patients when both conditions below are met:
The patient has symptomatic paroxysmal or permanent high-grade arteriovenous block or symptomatic bradycardia-tachycardia syndrome or sinus node dysfunction (sinus bradycardia or sinus pauses);
The patient has a significant contraindication precluding placement of conventional single-chamber ventricular pacemaker leads such as any of the following:
History of an endovascular or cardiovascular implantable electronic device (CIED) infection or who are at high risk for infection
Limited access for transvenous pacing given venous anomaly, occlusion of axillary veins or planned use of such veins for a semi-permanent catheter or current or planned use of an AV fistula for hemodialysis
Presence of a bioprosthetic tricuspid valve.
The Micra transcatheter pacing system is considered investigational in all other situations in which the above criteria are not met.
