Sam Brusco, Associate Editor07.05.23
Abbott has gained U.S. Food and Drug Administration (FDA) approval for its Aveir dual chamber (DR) leadless pacemaker. According to the company, it’s the world’s first dual chamber leadless pacing system that treats abnormal or slow heart rhythms.
"Modern medicine has been filled with technological achievements that fundamentally changed how doctors approach patient care, and now we can officially add dual chamber leadless pacing to that list of achievements," Vivek Y. Reddy, MD, director of cardiac arrhythmia services for the Mount Sinai Hospital and the Mount Sinai Health System, told the press. "In delivering a true dual chamber leadless pacemaker system, Abbott is expanding access to the benefits of leadless pacing to far more people than ever before and provided additional options to improve our ability to treat people with slow or abnormal heart rhythms."
Abbott’s i2i communication tech offers synchronized or coordinated cardiac pacing between two leadless pacemakers based on clinical needs. High-frequency pulses relay messages via the blood’s naturally conductive characteristics between each pacemaker.
Each implant communicates beat-to-beat with a paired, co-implanted device. This conductive communication uses less battery current than inductive, radiofrequency, or Bluetooth communication.
Aveir DR is about one-tenth the size of a traditional pacemaker—shorter, smaller, and slimmer than a AAA battery. It’s made up of two devices:
Leadless devices are implanted directly into the heart via a minimally invasive procedure and remove the need for cardiac leads. The device attaches to the heart’s interior with a screw-in mechanism (helix) that permits future device retrieval. Aveir DR also provides real-time pacing analysis so physicians can evaluate proper device placement.
Leadless pacemakers reduce exposure to potential lead and infection-related complications, and have a less restrictive and shorter recovery period.
"Leadless pacemakers have been limited to a single chamber device because seamless, wireless synchronization of two pacemakers has been an insurmountable engineering challenge—until now," said Randel Woodgrift, senior vice president of Abbott's cardiac rhythm management business. "Our team of dedicated scientists and engineers solved one of medtech's complex challenges in treating abnormal heart rhythms with the AVEIR pacemaker, a tiny device packed with powerful technology."
"Modern medicine has been filled with technological achievements that fundamentally changed how doctors approach patient care, and now we can officially add dual chamber leadless pacing to that list of achievements," Vivek Y. Reddy, MD, director of cardiac arrhythmia services for the Mount Sinai Hospital and the Mount Sinai Health System, told the press. "In delivering a true dual chamber leadless pacemaker system, Abbott is expanding access to the benefits of leadless pacing to far more people than ever before and provided additional options to improve our ability to treat people with slow or abnormal heart rhythms."
Abbott’s i2i communication tech offers synchronized or coordinated cardiac pacing between two leadless pacemakers based on clinical needs. High-frequency pulses relay messages via the blood’s naturally conductive characteristics between each pacemaker.
Each implant communicates beat-to-beat with a paired, co-implanted device. This conductive communication uses less battery current than inductive, radiofrequency, or Bluetooth communication.
Aveir DR is about one-tenth the size of a traditional pacemaker—shorter, smaller, and slimmer than a AAA battery. It’s made up of two devices:
- The previously approved Aveir VR single-chamber device to pace the right ventricle
- The now-approved Aveir AR single-chamber device to pace the right atrium
Leadless devices are implanted directly into the heart via a minimally invasive procedure and remove the need for cardiac leads. The device attaches to the heart’s interior with a screw-in mechanism (helix) that permits future device retrieval. Aveir DR also provides real-time pacing analysis so physicians can evaluate proper device placement.
Leadless pacemakers reduce exposure to potential lead and infection-related complications, and have a less restrictive and shorter recovery period.
"Leadless pacemakers have been limited to a single chamber device because seamless, wireless synchronization of two pacemakers has been an insurmountable engineering challenge—until now," said Randel Woodgrift, senior vice president of Abbott's cardiac rhythm management business. "Our team of dedicated scientists and engineers solved one of medtech's complex challenges in treating abnormal heart rhythms with the AVEIR pacemaker, a tiny device packed with powerful technology."