Welcome healthcare public relations professionals to the online resource kit for the Medtronic Micra™ VR and Micra™ AV Transcatheter Pacing Systems (TPS). Materials on this page have been provided as a courtesy by the Medtronic Public Relations team for your use in developing materials for media or supporting their requests for information.
Please note: Medtronic is required by regulatory authorities to provide complete, balanced information about the benefits and risks of our products, which is included in the documents provided on this website. We request that you include this information as well when communicating with your audiences about Medtronic products
Please contact your Medtronic representative to learn more about adding your information to the physician finder. Medtronic offers an online physician finder that enables patients to search for an experienced Micra transcatheter pacing system implanter by entering their zip code.
Include a link to Pace of Mind on your hospital or clinic website so patients can easily learn more about Micra and view patient testimonials. Medtronic, in collaboration with Mended Hearts, offers a patient website designed to educate people with heart conditions about Micra and leadless pacing. Pace of Mind provides educational resources for patients who have learned they need a pacemaker, including information on leadless pacemakers, what to expect before, during and after the procedure, and how to discuss pacing options with their physician. The website also shares personal stories of adults living with leadless pacemakers.
Brief Statement: Micra™ and Micra™ AV
Indications (or Intended Use)
Micra devices, Micra Model MC1VR01 and Micra AV Model MC1AVR1, are indicated for use in patients who have experienced one or more of the following conditions:
Symptomatic paroxysmal or permanent high grade AV block in the presence of AF
Symptomatic paroxysmal or permanent high grade AV block in the absence of AF, as an alternative to dual chamber pacing when atrial lead placement is considered difficult, high risk, or not deemed necessary for effective therapy
Symptomatic bradycardia-tachycardia syndrome or sinus node dysfunction (sinus bradycardia/sinus pauses), as an alternative to atrial or dual chamber pacing when atrial lead placement is considered difficult, high risk, or not deemed necessary for effective therapy
Micra AV Model MC1AVR1 is also indicated for VDD pacing in patients with adequate sinus rates who may benefit from maintenance of AV synchrony. The Micra AV device provides AV synchronous ventricular pacing similar to a transvenous VDD system. The implanted device depends on the appropriate sensing of atrial mechanical signals to achieve AV synchrony. The level of AV synchrony may vary in individual patients and may not be predictable prior to implant.
Rate-responsive pacing is indicated to provide increased heart rate appropriate to increasing levels of activity. The device is designed to be used only in the right ventricle.
Micra Model MC1VR01 and Micra AV Model MC1AVR1 are 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 device is contraindicated for patients who have the following conditions: femoral venous anatomy unable to accommodate a 7.8 mm (23 French) introducer sheath or implant on the right side of the heart (for example, due to obstructions or severe tortuosity), morbid obesity that prevents the implanted device from obtaining telemetry communication within ≤ 12.5 cm (4.9 in), 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 if the steroid dose from this device cannot be tolerated.
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. For Micra Model MC1VR01, asynchronous VVIR pacing with sinus rhythm may not be appropriate when competitive pacing is considered undesirable or causes symptoms of pacemaker syndrome. 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.
For Micra AV Model MC1AVR1, 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, acceleration of tachycardia, necrosis, myocardial infarction 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. For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at medtronic.com.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.