FDA approves first dual-chamber leadless pacing system
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Key takeaways:
- The world’s first dual-chamber leadless pacing system has been approved by the FDA.
- The technology will enable more patients to have a leadless pacemaker and avoid complications associated with pacemaker leads.
Abbott announced that the FDA approved the world’s first dual-chamber leadless pacing system, which will open up leadless pacemaker technology to a broader population.
The system (Aveir DR) consists of two leadless pacemakers, one implanted in the right ventricle and one implanted in the right atrium, according to a press release issued by Abbott.
“The concept of leadless pacing has been around for a while, [but] existing devices are only ventricular pacemakers, so they only pace the bottom chamber of the heart,” Vivek Y. Reddy, MD, director of cardiac arrhythmia services at Mount Sinai Hospital and the Mount Sinai Health System, told Healio. “What is different about the Aveir device is that it is two separate devices that pace both the bottom and the top chamber of the heart. They communicate. Depending on which country you look at, the incidence of single-chamber pacemakers being employed vs. dual-chamber pacemakers being employed is on the order of 10% to 20%. In the U.S. it is closer to 10%. While leadless pacemakers have been an exciting and important advance in pacing, they have not had as big a potential impact because the percentage of the patient population appropriate for leadless pacemakers has been somewhat limited. The Aveir device changes the game a bit, because now most patients who require pacing have suddenly become potentially eligible for leadless pacing.”
Through a communication technology (i2i, Abbott), the system provides synchronized or coordinated cardiac pacing between the two leadless pacemakers, according to the release.
The system was approved based on the results of the Aveir DR i2i investigational device exemption trial, in which, as Healio previously reported, the technology met 3-month safety and performance goals, including a 98.3% rate of implantation success and a 97% rate of successful atrioventricular synchrony.
Single-chamber leadless pacemakers cannot be used in patients with atrioventricular block or sinus node dysfunction, who make up the majority of patients who need pacing, Reddy told Healio.
“In the Aveir DR trial, around two-thirds of the patients enrolled in the trial were sinus node dysfunction patients. In the trial, it was being used in the kinds of patients we put pacemakers into, in the same ratio,” he said. “As far as who are the ideal patients ... the reality is that probably everyone could benefit. The reason leadless pacemakers were developed was because of complications with the lead. Every traditional pacer uses leads. Avoiding the lead and its potential complications is what makes the leadless pacemaker attractive.”
Also notable about the trial was the low rate of complications despite every operator having no prior experience implanting the system, Reddy told Healio.
“We were pleasantly surprised at how safe the device ended up being,” he said. “In 300 patients, despite operators doing the procedure for the first time ... and the thinness of the atrial tissue, the safety was quite good and I was impressed with it. There were a couple of arrhythmias that went in the safety endpoint, but the dislodgement rate was only 1.5% and there was only one pericardial effusion that required an intervention. We will know more as this elaborates into the community, but the fact is, we are starting at a stage where it ended up being safe with a lot of different operators from a lot of different centers.”
For more information:
Vivek Y. Reddy, MD, can be reached at vivek.reddy@mountsinai.org; Twitter: @vivekreddymd.
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