Abbott Receives FDA Approval for World’s First Dual Chamber Leadless Pacemaker

What You Should Know: 

• The U.S. Food and Drug Administration (FDA) approves Abbott’s AVEIR™ dual chamber (DR) leadless pacemaker system, the world’s first dual chamber leadless pacing system that treats people with abnormal or slow heart rhythms.
• Abbott’s breakthrough technology enables the world’s first beat-to-beat, wireless communication and synchronization between two leadless pacemakers, which are smaller than a AAA battery
• Leadless pacemakers provide a new minimally invasive option that will revolutionize care for more people in the U.S. who need pacing to treat a variety of slow or abnormal heart rhythms

World’s First Dual Chamber Leadless Pacemaker

Unlike traditional pacemakers, leadless devices are implanted directly into the heart through a minimally invasive procedure and eliminate the need for cardiac leads. As a result, leadless pacemakers reduce people’s exposure to potential lead and infection-related complications and offer a less restrictive and shorter recovery period post-implantation.

Through Abbott’s proprietary i2i™ communication technology, AVEIR DR devices provide synchronized or coordinated cardiac pacing between two leadless pacemakers based on the person’s clinical needs. The i2i technology utilizes high-frequency pulses to relay messages via the naturally conductive characteristics of the body’s blood between each leadless pacemaker. To support dual chamber therapy, each implant communicates beat-to-beat with a paired, co-implanted device. This conductive communication is critical, because it uses far less battery current than inductive, radio frequency or Bluetooth® communication which are other alternatives used in implantable medical devices or traditional pacemakers.

Roughly one-tenth the size of a traditional pacemaker, the AVEIR DR leadless pacing system is made up of two devices – the previously-approved AVEIR VR single chamber device, which paces the right ventricle, and the now-approved AVEIR AR single chamber device, which paces the right atrium. The AVEIR DR system incorporates Abbott’s novel i2i technology, which solves a significant engineering challenge by offering beat-to-beat communication between the two leadless pacemakers.

Slimmer Than a AAA Battery

Shorter, smaller and slimmer than a AAA battery, each AVEIR pacemaker is implanted via a minimally invasive procedure. The device attaches to the heart’s interior surface with a screw-in mechanism – known as a helix – that allows for future retrieval of the device should therapy needs evolve, or if the device needs to be replaced in the future. The AVEIR DR system is also designed to provide real-time pacing analysis, so physicians can assess proper placement of the device during the procedure and before implanting the device to the inside of the heart chamber. 

“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.”

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