FDA OKs Abbott’s AVEIR VR Mini Ventricular Leadless Pacemaker

Abbott recently earned U.S. Food and Drug Administration (FDA) approval for its AVEIR VR Mini ventricular leadless pacemaker (LP), which boasts a shorter length to expand implant options in the right ventricle.

The AVEIR VR Mini Ventricular LP, alongside the AVEIR AR2 Atrial LP, marks the next evolution of Abbott’s AVEIR DR LP system, a dual-chamber leadless pacemaker. The system uses the company’s i2i (implant-to-implant) communication technology to enable beat-to-beat communication between two leadless pacemakers and maintain synchronized cardiac activation.

At 32.5 mm, the newly approved AVEIR VR Mini is 14% shorter than the existing 38.0-mm AVEIR VR Ventricular LP while maintaining ventricular longevity.  The smaller form factor provides another option for patients who may benefit from a lower-profile device.

Unlike traditional pacemakers, leadless systems are implanted directly in the heart through a minimally invasive, catheter-based procedure, eliminating the need for cardiac leads. The approach leaves no chest incision or visible device.

“Abbott is advancing leadless pacing and expanding options for physicians and patients,” said Randel Woodgrift, senior vice president of Abbott’s cardiac rhythm management 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.”

Last year, the company released late-breaking data from its AVEIR conduction system pacing (CSP) acute clinical feasibility study, which evaluated safety and performance of the investigational AVEIR CSP leadless pacemaker.