This follows the late June FDA approval of its Aveir DR system — a dual-chamber leadless pacemaker that Abbott says is the first of its kind. However, Medtronic‘s dual-chamber leadless pacemaker, named Micra AV2, was approved by the FDA in May, and Boston Scientific is developing a dual-chamber leadless pacemaker as well.
Aveir DR is a better option than Medtronic’s Micra AV2 because it is “the only leadless system that is able to provide atrial pacing for patients that need it,” said Matthew Fishler, chief engineer and director of product development at Abbott’s cardiac rhythm management business, said in an email. Micra AV2 is only implanted in the right ventricle, so it cannot provide that type of therapy, he declared. In other words, Micra AV2 can deliver ventricular therapy, whereas the AVEIR DR system can achieve full ventricular and atrial therapy.
Additionally, Aveir DR has demonstrated its ability to achieve greater than 95% atrioventricular synchrony across many different postures, activity levels and heart rates, “whereas the AV synchrony capability of Micra AV2 is more limited, especially as the heart rate increases,” Fishler noted. AV synchrony occurs when the atrium and the ventricle are paced simultaneously — this synchronization creates a heart rhythm resembling two parts of a song coming into harmony.
Although both Aveir DR and Micra AV2 are dual-chamber leadless pacemakers, an analyst believes the former will help Abbott take market share from Medtronic.
While Aveir DR hit the market after Medtronic’s Micra AV2, Abbott’s device is “the first true dual-chamber option covering sinus node dysfunction in addition to AV block with a profile potentially more suited for younger patients due to its retrievability,” according to a research note that J.P. Morgan Analyst Robbie Marcus published in May.
This means that Abbott’s pacemaker sends electrical impulses to stimulate the heart and help it beat at an appropriate rate, as well as stimulates the ventricles when it detects a delay or block in the natural conduction of impulses from the atria to the ventricles. Aveir DR is also easy to retrieve if it needs to be replaced, which is highly likely if it’s implanted into a younger patient.
“Said another way, Micra today can address ~50% of the pacemaker market, or less depending on the market data source, while Aveir family can address 100% of the market,” Marcus wrote.
Leadless pacemakers are an important innovation in the history of pacemakers.
Traditional pacemakers implanted in a patient’s chest run wires called “leads” into the heart, which can cause inconveniences like a restricted range of motion in patients. These wires also introduce risks for complications, such as fractures or insulation breaches, as well as lead-related venous thrombosis and obstruction.
The Aveir DR system — consisting of two modules that are smaller and thinner than AAA batteries — gets implanted directly in the heart ventricle via a minimally invasive procedure without any leads or chest scars.
The availability of Aveir DR seeks to increase patients’ access to leadless pacing given that more than 80% of people who need a pacemaker require pacing in two chambers of the heart (both the right atrium and right ventricle), according to Abbott. Having the option of leadless pacing would typically mean they can participate in more physical activities and experience less complications, said Vish Charan, divisional vice president of product development at Abbott’s cardiac rhythm management business, in an interview. For example, people with leadless pacemakers are free to raise their hands or swing a golf club, whereas those with a traditional pacemaker may not be able to, he said.
There is a corkscrew-like helix at the bottom of the two implants. Within this helix, there is a small tip electrode for sensing and providing pacing stimulation, and there is also a return electrode at the opposite end of the implant. The pacemakers produce electrical pulses to get slow or irregular heartbeats back on track, as well as communicate with each other to synchronize their pacing.
“It’s historic because pacemakers have not changed in 60 years. This is the first time we have two capsule-size devices implanted in the heart wirelessly communicating with each other and taking away all the complexity and challenges that come with a traditional pacemaker system. Those have served us well, but we have to look at the future. This is where the future is going: miniaturized devices,” Charan explained.
Additionally, the traditional method for pacemaker insertion includes creating a “pocket” in the chest for the pacemaker, which often results in a noticeable bump on a patient’s chest. With Aveir DR, there’s no bump — doctors make a small incision near the patient’ femoral vein and the device is implanted from there, Charan noted.
Abbott’s pacemaker began being implanted last week in patients across the nation who are managing an abnormal or slow heartbeat. Some health systems that have begun implanting Aveir DR include Mount Sinai, Providence, MedStar Health and Weill Cornell Medicine.
The pacemaker represents a breakthrough that is “like the difference between dial-up internet and high-speed Wi-Fi,” according to Dr. Brian Kim, a Providence cardiology specialist who performed the health system’s first Aveir DR implantation.
“With a majority of patients having need for dual chamber control, and the increased longevity this new technology affords clinicians, more and younger patients will benefit from this game changing device,” he said in a statement.