FDA NewsPerspective

FDA approves leadless pacemaker to treat arrhythmia disorders

The FDA has approved the first pacemaker that does not require wired leads to generate the electrical impulses needed to treat arrhythmia disorders, according to press releases from the agency and Medtronic.

The leadless pacemaker (Micra Transcatheter Pacing System, Medtronic), is a self-contained, 1-in. device implanted in the right ventricle, according to the releases.

“As the first leadless pacemaker, Micra offers a new option for patients considering a single-chamber pacemaker device, which may help prevent problems associated with the wired leads,” said William Maisel, MD, MPH, acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health in the FDA press release.

William Maisel

The approval was based on data from a global clinical trial in which 719 patients were implanted with the Micra device, in which 98% percent of the patients experienced adequate pacing capture threshold 6 months after implantation and fewer than 7% experienced complications. Complications included prolonged hospitalization, deep vein and pulmonary thrombosis, heart injury, device dislocation and MI.

“In the clinical trial, the Micra was successfully implanted in nearly all patients, and met its safety and effectiveness endpoints by wide margins,” Dwight Reynolds, MD, regent’s professor and chief of the cardiovascular section at the University of Oklahoma Health Sciences Center, who was principal investigator of the trial, said in the Medtronic release. “This gives us great confidence that this miniaturized device will bring patients the most advanced pacing technology, combined with the less-invasive nature of the new technology.”

The device is intended for patients with atrial fibrillation and other arrhythmias such as bradycardia-tachycardia syndrome, but is not suitable for patients who have implanted devices that would interfere with the pacemaker, those who are severely obese, or those who have veins that cannot accommodate the 7.8-mm introducer sheath or pacemaker implant, according to the FDA press release.

Disclosures: Maisel is an employee of the FDA. Reynolds reports consulting for Medtronic.

The FDA has approved the first pacemaker that does not require wired leads to generate the electrical impulses needed to treat arrhythmia disorders, according to press releases from the agency and Medtronic.

The leadless pacemaker (Micra Transcatheter Pacing System, Medtronic), is a self-contained, 1-in. device implanted in the right ventricle, according to the releases.

“As the first leadless pacemaker, Micra offers a new option for patients considering a single-chamber pacemaker device, which may help prevent problems associated with the wired leads,” said William Maisel, MD, MPH, acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health in the FDA press release.

William Maisel

 

The approval was based on data from a global clinical trial in which 719 patients were implanted with the Micra device, in which 98% percent of the patients experienced adequate pacing capture threshold 6 months after implantation and fewer than 7% experienced complications. Complications included prolonged hospitalization, deep vein and pulmonary thrombosis, heart injury, device dislocation and MI.

“In the clinical trial, the Micra was successfully implanted in nearly all patients, and met its safety and effectiveness endpoints by wide margins,” Dwight Reynolds, MD, regent’s professor and chief of the cardiovascular section at the University of Oklahoma Health Sciences Center, who was principal investigator of the trial, said in the Medtronic release. “This gives us great confidence that this miniaturized device will bring patients the most advanced pacing technology, combined with the less-invasive nature of the new technology.”

The device is intended for patients with atrial fibrillation and other arrhythmias such as bradycardia-tachycardia syndrome, but is not suitable for patients who have implanted devices that would interfere with the pacemaker, those who are severely obese, or those who have veins that cannot accommodate the 7.8-mm introducer sheath or pacemaker implant, according to the FDA press release.

Disclosures: Maisel is an employee of the FDA. Reynolds reports consulting for Medtronic.

    Perspective
    John D. Day MD, FHRS, FACC

    John D. Day

    This is great news for patients. Pacemaker leads, as well as the pacemaker generator placed under the skin, have long been the Achilles’ heel of pacemaker therapy. With a fully contained pacemaker system, inside of the heart, this will overcome many of the shortcomings of current pacemaker therapy, such as lead fracture, pocket hematomas, or pacemaker erosion.

    The challenge is that only a very small percentage of patients in clinical practice will actually benefit from this current-generation device. This pacemaker can only provide single-chamber pacing to the right ventricle of the heart. As such, this device is really only suitable for patients with permanent AF and a slow heart rate that causes symptoms. I look forward to future generations of leadless pacemakers where multi-chamber heart pacing will be available and more patients can benefit from this new technology.

    Early adopters of this new technology may see increased risks with the implantation procedure, including cardiac tamponade or device dislodgment. However, with experience and technology improvements, any increased risk should resolve over time.

    • John D. Day, MD, FHRS
    • Director, Heart Rhythm Services
      Intermountain Medical Center, Murray, Utah
      President, Heart Rhythm Society

    Disclosures: Day reports no relevant financial disclosures.