AVEIR DR Dual Chamber Leadless Pacemaker System

About

Why AVEIR Dual Chamber

Introducing the World's First and Only Dual Chamber Leadless Pacemaker System¹

Brought to you only by Abbott, the AVEIR DR™ Dual Chamber Leadless Pacemaker (LP) System is first-of-its-kind technology that provides:

Beat-to-Beat Synchrony between both chambers.^2,3
Upgradeable from single to dual chamber therapy.²
Long-Term Retrieval to remove hardware at end of service (EOS).^2,4
Electrical Mapping Before Fixation to reduce repositioning.^2,3

Our life-changing technology provides all the clinical benefits of traditional dual chamber pacemakers without the downsides. This means:

NO pocket- and lead-related complications (including infection, lead fracture, insulation problems, skin erosion and keloid formation).
NO visible scarring.
NO arm movement restrictions post-implantation.

Beat-to-Beat Synchrony^2,3

AVEIR™ DR Leadless Pacemaker System is capable of pacing and sensing in both chambers through the combination of an atrial leadless pacemaker (AVEIR™ AR LP) and a ventricular leadless pacemaker (AVEIR™ VR LP).

Dual chamber, leadless synchronous pacing between the atrium and the ventricle is made possible with industry-first, proprietary i2i™ communication technology capable of providing true DDD(R) pacing for continuous, atrioventricular (AV) synchrony, regardless of patient posture.

Mean AV synchrony observed for multiple postures and gaits (including sitting, supine, left lateral recumbent, right lateral recumbent, standing, normal walking and fast walking).³

Implant-to-Implant (i2i™) Technology²

This novel technology features paired, co-implanted devices employing low-energy, subthreshold pulses between them using the conductive nature of the body’s blood pool and myocardial tissue.

High-frequency pulses are delivered concurrently with each locally paced or sensed event without impact on pacing or intrinsic sensing.

Upgradeable System²

Patient therapy can be tailored by implanting an atrial or ventricular device alone, or both combined, for dual chamber support. The option to upgrade over time allows you to:

Meet your patients’ needs today
Adapt to common disease progression to meet your patients’ needs in the future

Treatment option 1: Start with the atrial device.

Treat sinus node dysfunction today.

Add a ventricular device for heart block later.

i2i™ communication is enabled.

Activate dual chamber pacing therapy DDD(R) via i2i Communication.

Treatment option 2: Start with the ventricular device.

Treat rare intermittent heart block today.

Add an atrial device for sick sinus syndrome later.

i2i communication is enabled.

Activate dual chamber pacing therapy DDD(R) via i2i communication.

Long-term Retrieval^2,4,5

This allows for the replacement of the atrial or ventricular device at end of service (EOS) without leaving hardware behind.

The AVEIR™ VR ventricular leadless pacemaker predicate device has a long-term retrieval success rate above 88% with helix fixation through 9 years regardless of implant duration.⁴

Retrieval Success by Implant Duration⁴

The specially designed retrieval catheter provides added confidence and is supported by a step-by-step retrieval protocol.⁵ AVEIR™ devices have an active fixation design that uses a screw-in mechanism to enable both implantation and long-term retrieval of the atrial and ventricular devices.²

See How It Works

Mapping Prior to Fixation^2,3

Electrical mapping prior to fixation is designed to help reduce the number of repositioning attempts in the atrium and ventricle. AVEIR™ Leadless Pacemakers can assess Current of Injury via Commanded EGM, initial pacing capture thresholds, sensing amplitudes, and impedance in both atrial and ventricular chambers.

of patients had successful VENTRICULAR IMPLANTS WITH 1 OR LESS REPOSITIONING ATTEMPTS.³

of patients had successful ATRIAL IMPLANTS WITH 1 OR LESS REPOSITIONING ATTEMPTS.³

Proven Clinical Evidence³

Across 300 attempted implants, the procedure was successful in 295 patients for a

Dual Chamber Procedure Success Rate³

View safety and efficacy results observed at the three-month follow-up of the AVEIR™ DR i2i™ Study as cited in the New England Journal of Medicine.

See the Data

References

AVEIR™ DR CE Mark and FDA approval.
AVEIR™ Leadless Pacemakers and Delivery Catheter IFU, ARTEN600307044.
Knops, Reinoud E., et al. "A Dual-Chamber Leadless Pacemaker." New England Journal of Medicine (2023). DOI: 10.1056/NEJMoa2300080
Reddy, VY, et al. Worldwide Experience with Leadless Pacemaker Retrievals: A Worldwide Nanostim Experience out of 9y. Presented at: APHRS 2022; Nov 18-20, 2022; Singapore.
AVEIR™ Retrieval Catheter IFU. ARTMT600167676.

MAT-2406381 v1.0

CARDIOVASCULAR

AVEIR DR Dual Chamber Leadless Pacemaker System