World’s Smallest Pacemaker Gets FDA Approval

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    Micra model MC1VR01 is contraindicated for patients who have the following types of medical devices implanted: an implanted device that would interfere with the implant of the Micra device in the judgment of the implanting physician, an implanted inferior vena cava filter, a mechanical tricuspid valve, or an implanted cardiac device providing active cardiac therapy that may interfere with the sensing performance of the Micra device.

    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 the 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.

    The device is contraindicated for patients who have the following conditions: femoral venous anatomy unable to accommodate a 7.8 mm introducer sheath or implant on the right side of the heart, morbid obesity that prevents the implanted device from obtaining telemetry communication within ≤12.5 cm, or known intolerance to the materials listed in the Instruction for Use, or to heparin, or sensitivity to contrast media that cannot be adequately premedicated, or where a single dose of 1.0 mg dexamethasone acetate may be contraindicated.

    The following may be contraindications to Micra VVIR pacing.

    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.

    End of Service – 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.

    Potential complications include, but are not limited to, toxic/allergic reaction, oversensing, acceleration of tachycardia, myocardial infarction and surgical complications such as cardiac perforation, pericardial effusion, cardiac tamponade, death, device embolization, access site hematoma and AV fistulae, vessel spasm, infection, 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 restricts these devices to sale by or on the order of a physician.

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