Abbott, known worldwide for its healthcare innovation, has introduced the AVEIR VR ventricular leadless pacemaker in India, targeting patients with bradycardia. The device has secured approval from both the Central Drugs Standard Control Organization (CDSCO) in India and the US Food and Drug Administration (FDA). It embodies a milestone in cardiovascular care, offering new functionalities to both patients and healthcare professionals.
For individuals suffering from bradycardia, traditional pacemakers help regulate the heart by emitting electrical impulses that ensure proper heartbeats. Conventional pacemakers necessitate a surgical incision to create a pocket for the generator and use cardiac leads to transmit impulses. By contrast, the leadless pacemaker eliminates the need for a generator pocket and leads. Instead, it is placed directly into the heart’s right ventricle through a minimally invasive catheter procedure performed via the groin, thus avoiding chest incisions.
A standout feature of this device is its advanced mapping capability, which permits physicians to assess heart electrical signals and select the optimal implant location. Its longevity surpasses that of existing leadless models, thus extending benefits to a broader patient population. Moreover, AVEIR is distinguished as the sole leadless pacemaker that can be retrieved if a replacement is necessary or treatment plans change.
“Leadless pacemaker systems intrigue us due to their potential to enhance care while minimizing invasive procedures,” explained Dr. Vanita Arora, the clinical head of electrophysiology at Apollo Hospitals Delhi. “Retrievability is crucial when anticipatory therapy adjustments are a factor,” she added.
Ajay Singh Chauhan, Abbott’s Cardiac Rhythm Management general manager for the Indian and Southeast Asian regions, emphasized, “The design of the AVEIR VR allows for smooth implantation and retrieval experiences for clinicians, providing significant upgrades over current options.”
“The standout elements of this advancement are its prolonged battery duration, unparalleled mapping ability, and earnings potential for retrievability. Our ambition is to build upon the introduction of the AVEIR VR, setting the stage for more pioneering products in abnormal heart rhythm treatments,” Chauhan remarked.
Global LEADLESS II investigational studies assessed AVEIR VR’s effectiveness in addressing select irregular heart rhythms, with results fulfilling the predetermined primary goals. These findings were shared at the Asia Pacific Heart Rhythm Society’s annual Scientific Sessions in November 2021 and were also published in the Journal of the American College of Cardiology: Clinical Electrophysiology.