Abbott launches AVEIR VR leadless pacemaker system in India to treat patients with slow heart rhythms

New Delhi: Abbott, the global healthcare company announced the launch of AVEIR™ VR single-chamber ventricular leadless pacemaker for the treatment of patients in India with slow heart rhythms.

This pacemaker is now approved by Central Drugs Standard Control Organization (CDSCO) in India. It is also U.S. Food and Drug Administration (FDA) approved and marks a significant advancement for patient care bringing new features to patients and their physicians.

People who experience slower-than-normal heart rhythm may receive a pacemaker to deliver pulses of electricity to trigger the heart to beat properly. While traditional pacemakers require a chest incision and pocket for the generator along with one or more insulated wires – known as cardiac leads – to deliver electricity to the heart, leadless pacemakers do not require a pocket or leads. Instead, the device is implanted directly into the heart’s right lower chamber (right ventricle) via a minimally invasive, catheter-based procedure from the groin. Therefore, there is no incision made to the chest, no wires, and no pocket in the chest for a generator.

The device has a unique mapping capability designed to allow physicians to measure electrical signals within the heart and determine the best placement of the device before final implantation. The increased projected battery longevity over current available leadless pacemakers opens the door to more patients. In addition, AVEIR is the only leadless pacemaker designed to be retrieved if the device needs to be replaced or therapy needs evolve.

“What make leadless pacemaker systems unique is that they have the potential to help us advance treatment for people who need a pacemaker, but as physicians, we are concerned about more invasive surgery. Additionally, in some circumstances where we believe a person’s therapy needs may change in the future, retrievability also becomes a critical device feature,” says Dr. Vanita Arora, Clinical Lead Electrophysiology, Apollo Hospitals Delhi.

“The AVEIR VR leadless pacemaker was designed to make the implantation and retrieval processes as seamless as possible for physicians and provide improvements over existing options,” said Ajay Singh Chauhan, General Manager for Abbott’s Cardiac Rhythm Management business in India, Southeast Asia, HK, Taiwan & Korea. ” What sets this innovation apart is the impressive battery life and unique mapping capability and retrievability. Our goal is to continue to build on the introduction of AVEIR VR to provide more first-of-their-kind products in the future, revolutionizing how abnormal heart rhythms are treated.”

Data from the global LEADLESS II investigational device exemption (IDE) study evaluated AVEIR VR in patients with certain abnormal heart rhythms. The results showed the device met its pre-specified primary endpoints. The findings were presented at the annual Scientific Sessions of the Asia Pacific Heart Rhythm Society (APHRS) in November 2021 and simultaneously published in the Journal of the American College of Cardiology: Clinical Electrophysiology.