Abbott has obtained CE Mark approval in Europe for its AVEIR dual chamber (DR) leadless pacemaker system, designed to treat patients with abnormal or slow heart rhythms.
The AVEIR DR system is a pioneering technology enabling wireless, beat-to-beat communication between two leadless pacemakers, addressing the needs of individuals with irregular heart rhythms and expanding treatment options in Europe. The system comprises two devices: one for pacing the right ventricle (AVEIR VR) and one for pacing the right atrium (AVEIR AR), each significantly smaller than traditional pacemakers.
Unlike conventional pacemakers that use cardiac leads and are implanted under the skin, leaving visible scars and bulges, leadless pacemakers are directly implanted into the heart via a minimally invasive procedure. This approach reduces the risk of lead and infection-related complications and offers a less restrictive, shorter recovery period.
Professor Reinoud Knops of Amsterdam University Medical Center remarked that receiving the CE Mark for AVEIR DR is a milestone in European cardiac care, revolutionizing the treatment of heart rhythm disorders and reducing complication risks.
As reported by Medical Dialogues, Abbott’s i2i (implant-to-implant) communication technology in the AVEIR DR system ensures synchronized pacing between the two leadless pacemakers. This system uses high-frequency pulses for communication, requiring less battery power than other methods like Bluetooth.
Dr. Leonard Ganz of Abbott highlighted that AVEIR DR meets a crucial need for patients with slow heart rhythms, improving their quality of life with its innovative design. The AVEIR DR system achieved high safety and efficacy rates in clinical trials and received U.S. FDA approval in June 2023.