Micra™ AV2 Leadless Pacemaker ISW
Indications (or intended use)
Micra™ AV2 Model MC2AVR1 is indicated for VDD pacing in patients when a dual chamber transvenous pacing system is considered a poor option or not deemed necessary for effective therapy, and when a right ventricular transcatheter pacing system promoting atrioventricular (AV) synchrony at rest is acceptable. Conditions when a patient is considered a poor candidate for transvenous pacing may include, but are not limited to, tortuous anatomy, a need to preserve venous access, or increased risk of infection. The device provides AV synchrony at rest and rate responsive (VVIR) pacing during periods of high patient activity.
Device-mediated AV synchrony can vary depending on patient condition and activity levels, and it can be limited at high sinus rates. During periods of intermittent AV synchrony, the device will provide ventricular pacing support with an increased potential for pacing rate variability. Micra™ AV2 is indicated for use in patients who have experienced one of the following:
- Paroxysmal or permanent high-grade AV block in the presence of atrial fibrillation (AF)
- Paroxysmal or permanent high-grade AV block in the presence of paroxysmal AF
- Paroxysmal or permanent high-grade AV block in the presence of persistent AF when attempts at restoring sinus rhythm are still planned
The device is designed to be used only in the right ventricle.
Contraindications
Micra™ AV2 Model MC2AVR1 devices are contraindicated for use in the following situations:
- If an implanted inferior vena cava filter is present and jugular venous anatomy is unable to accommodate a 7.8 mm (23 Fr) introducer sheath or implant on the right side of the heart (for example, due to obstructions or severe tortuosity).
- If a mechanical tricuspid valve is present
- If another implanted cardiac device providing active cardiac therapy may interfere with the sensing performance of the Micra™ AV2 device
- If another implanted device would interfere with the implant of the Micra™ AV2 device in the judgment of the implanting physician
- If venous anatomy is unable to accommodate a 7.8 mm (23 Fr) introducer sheath or implant on the right side of the heart (for example, due to obstructions or severe tortuosity)
- If morbid obesity prevents the implanted device from obtaining adequate telemetry communication within 12.5 cm (4.9 in)
- If known intolerance to heparin or the tissue contacting materials in the device exists
- If sensitivity to contrast media cannot be adequately premedicated
- If the steroid dose from this device cannot be tolerated
For the MRI contraindications for patients with a Micra™ AV2 MRI device, refer to the Micra™ AV2 MRI technical manual.
Warnings and precautions
End of service (EOS): When the EOS condition is met, the clinician has the option of permanently programming the device to “off” and leaving it in the heart, or retrieving the device, provided the device has not yet become encapsulated. Removal of the Micra™ device after it has become encapsulated may be difficult because of the development of fibrotic tissue. If removal of the device is required, it is recommended that the removal be performed by a clinician who has expertise in the removal of implanted leads.
MRI conditions for use: Before an MRI scan is performed on a patient implanted with the Micra™ device, the cardiology and radiology professionals involved in this procedure must understand the requirements specific to their tasks as defined in the device manuals.
Rate-responsive mode may not be appropriate for patients who cannot tolerate pacing rates above the programmed “lower rate.” The patient’s age and medical condition should be considered by physicians and patients as they select the pacing system, mode of operation, and implant technique best suited to the individual.
Precautions should be taken before administering anticoagulant agents, antiplatelet agents, or contrast media in patients with known hypersensitivity to these agents.
The use of deactivated Micra™ devices in situ and an active Micra™ device, or an active transvenous pacemaker or defibrillator, has not been clinically tested to determine whether EMI or physical interaction is clinically significant. Bench testing supports that implantation of an active Micra™ device, or an active transvenous pacemaker or defibrillator, next to an inactivated Micra™ device is unlikely to cause EMI or physical interaction. Post-approval studies are planned to characterize risks of co-implanted, deactivated Micra™ devices. Currently recommended end of device life care for a Micra™ device may include the addition of a replacement device with or without explanation of the Micra™ device, which should be turned off.
Patient activities and environments which present mechanical vibrations to the patient can interfere with the mechanical sensing of atrial contractions. This can result in a loss of AV synchrony.
Potential adverse events or potential complications
Potential complications include, but are not limited to, toxic/allergic reaction, oversensing, pacemaker syndrome, cardiac arrest, necrosis, and surgical complications such as cardiac perforation, pericardial effusion, cardiac tamponade, device embolization, hematoma, AV fistula, vessel dissection, infection, cardiac inflammation, and thrombosis.
See the device manuals for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, MRI conditions for use, and potential complications/adverse events.
Caution: Federal law (United States) restricts these devices to sale by or on the order of a physician.
MAJ_83734
