Abbott scores FDA approval for world's first leadless dual-chamber pacemaker

Patients who require rhythmic assistance in two chambers of the heart now have the option of a leadless system, after the US Food and Drug Administration (FDA) approved Abbotts AVEIR dual-chamber (DR) leadless pacemaker system.

The FDA nod came hot on the heels of clinical data announced by the medical device giant in May, demonstrating that 97% of participants had successful atrioventricular (AV) synchrony following device implant.

The AVEIR DR system is the first technology of its kind to consist of two pacemakers implanted directly into the heart myocardium without the need for leads. Traditional pacemakers require a more invasive procedure to install, and the limited lifespan of leads means that current systems last between 10 to 15 years.

There are leadless devices currently on the market, such as Medtronics Micra devices, but these are limited to single-chamber use. According to Abbott, 80% of patients who need a pacemaker require pacing in the right atrium and the right ventricle.

Abbotts two devices, each a little smaller than a AAA battery, communicate via the companys proprietary i2i technology which uses high-frequency pulses to achieve synchronicity.

The communication, which takes advantage of the conductive nature of the body to relay signals, also has fail-safes in case one device becomes out of step.

The system is designed that if one of the devices for that one beat misses the communication channel, we have multiple modes in the device for protection, Vish Charan, vice president of product development at Abbotts cardiac rhythm management department, told Medical Device Network.

It will look at the previous rhythm and appropriately make a decision on what to do based on the prior rhythm. If it loses multiple beats, there are other protections which are clinically acceptable.

Pacemakers are one of the biggest drivers of the cardiovascular device market. The dual-chamber pacemaker market is forecast to reach $5.8bn by 2033 according to a market model by GlobalData.

The AVEIR DR system is indicated for all types of pacemaker patients who kept pacemakers in todays form of two leads or even one lead into either one of the chambers. So, we have not sub-selected, and we have the entire market of patients and indications covered, said Charan.

Like anything, new technology will take time, such as the training required for physicians, but were excited about the future and the new option this provides for patients.

Charan added that the company is also working with regulatory bodies in Europe, with approval expected in early 2024.