FDA approves smaller leadless pacemaker from Abbott
The U.S. Food and Drug Administration (FDA) has approved Abbott's Aveir VR Mini Ventricular leadless pacemaker (LP). The new device is 14% shorter than the Aveir VR Mini Ventricular, shortened from 38 mm to 32.5 mm. According to Abbott, this offers an additional option to patients who require a lower-profile device, potentially expanding the number of patients who can be treated with a leadless pacing system. This approval also expands implant options in the smaller space of the right ventricle.
Abbott sees the Aveir AR2 Atrial LP and Aveir VR Mini Ventricular LP as the next step in the evolution of its Aveir DR LP, which is the world’s only dual-chamber leadless pacemaker system. These systems use a unique implant-to-implant, in-body communication between two leadless pacemakers implanted directly inside each ventricle to coordinate synchronous beating of the heart.
Leadless pacing was previously limited to patients who only needed single-ventricle pacing. With so many patients needing biventricular pacing, these systems have helped expand care to a larger percentage of patients.
“Abbott is advancing leadless pacing and expanding options for physicians and patients,” Randel Woodgrift, senior vice president of Abbott’s cardiac rhythm management business, told Cardiovascular Business. “Together, Aveir AR2 and Aveir VR Mini represent the next generation of the world’s only dual-chamber leadless pacing system, giving physicians a highly optimized atrial and ventricular pairing that expands the reach of this technology to a broader patient population.”
