The approval marks the first such nod for a dual-chamber leadless pacing system for treating abnormal or slow heart rhythms. According to Abbott, more than 80% of people who need a pacemaker require pacing in two chambers of the heart — the right atrium and right ventricle.
This approval “significantly increases access” to the pacing technology for millions in the U.S., Abbott said in a news release.
In contrast to Aveir dual-chamber leadless pacing, competitor Medtronic’s Micra AV is a single leadless pacemaker with several internal atrial sensing algorithms that detect cardiac movement. The Micra AV can adjust pacing in the ventricle to coordinate with the atrium, enabling it to provide “AV synchronous” pacing therapy to people with atrioventricular block.
Abbott’s approval follows clinical data shared in May that supported Aveir DR. The data came from the company’s large-scale FDA investigational device exemption (IDE) study. Results included a 98.3% implant success rate and more than 97% of patients presenting successful atrio-ventricular synchrony. Abbott said the data suggests that Aveir DR could offer new benefits for those with slower-than-normal 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,” said Dr. Vivek Y. Reddy, director of cardiac arrhythmia services for the Mount Sinai Hospital and the Mount Sinai Health System. “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.”
Earlier this year, MassDevice recently spoke with Dr. Leonard Ganz about Abbott’s cardiac rhythm management efforts. READ HERE.
More about the Abbott Aveir DR system
Aveir DR features Abbott’s proprietary i2i communication technology. This helps to provide synchronized or coordinated cardiac pacing between two leadless pacemakers based on clinical needs. Abbott designed the i2i technology to utilize high-frequency pulses. It relays messages through 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. The conductive communication uses far less batter current than inductive, radiofrequency or Bluetooth communication, Abbott said.
Two devices comprise Aveir DR, which comes in at roughly one-tenth the size of a traditional pacemaker (smaller than a AAA battery). Those devices — Aveir VR for the right ventricle and Aveir AR for the right atrium — incorporate the i2i technology. With this approach, beat-to-beat communication between the leadless pacemakers solves a significant engineering challenge, Abbott explained. It also provides real-time pacing analysis so physicians can assess the proper device placement during the procedure.
Leadless pacemakers are implanted directly into the heart through a minimally invasive procedure, eliminating the need for cardiac leads. This method reduces exposure to potential lead and infection-related complications. It also results in a less restrictive and shorter recovery period post-implant.
“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, SVP 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.”
