The US Food and Drug Administration approved the Aveir DR Dual Chamber Leadless Pacing System the first such model made by Abbott.
Each pacemaker is smaller than a AAA battery.
Unlike previous pacemakers, which required a small metal unit to be implanted in a pocket created under the skin on the patient's chest, in 2016 the FDA approved the first leadless pacemaker, which is a one-inch-long, self-contained device implanted in the right ventricular chamber of the heart.
Leadless pacemakers, including the Aveir, are placed directly into the heart using a small tube through a blood vessel in the leg.
“A dual-chamber leadless pacemaker is revolutionary,” said Dr. Cyrus Hadadi, a clinical cardiac electrophysiologist and associate director of cardiac arrhythmia research at MedStar Washington Hospital Center, who implanted the Aveir device in six patients during clinical trials.
“You have two units, one in the upper right chamber of the heart and one in the lower right, without wires, that communicate with each other to maintain the heart's natural rhythm,” Hadadi said.
While current single-chamber wireless units are only appropriate for certain conditions, Hadadi says the new dual-chamber system will greatly expand the number of patients that can be treated with wireless technology.
“The upper right chamber of your heart is the natural pacemaker. So, for the first time, you can place a pacemaker (without leads) in that upper right chamber to maintain the heart's natural rhythm. [desde] compression of the upper chamber, followed by compression of the lower chamber,” Hadadi said.
Batteries included, but they don't last forever.
The two components of the Abbott unit "talk to each other through your own bloodstream," through a technology called implant-to-implant, or "i2i," Hadadi said. The proprietary technology uses much less battery current than inductive, radio frequency or Bluetooth communication, according to Abbott.
“The battery life of this dual-chamber leadless pacemaker is, in many cases, better than that of an older traditional pacemaker – up to 8, 10 or 12 years,” Hadadi said.
The battery life of the pacemaker is partly determined by how often the unit paces.
“Some of us just need a little bit of rhythm once in a while, and some of us, unfortunately, have to be in it 100% of the time,” Hadadi said. "As you can imagine, that's going to consume the battery rate a little differently."
With some older leadless pacemakers, when battery life runs out, the original implant is left in the heart and simply shuts down when a second unit is placed.
Hadadi said Aveir's wireless pacemakers are designed to be removed and replaced when battery life runs out.
"So now, after 10 or 12 years, when the battery has died, in an outpatient procedure, your cardiologist can remove it from your body and put a new one in its place," he said.
Hadadi said that several of the patients in the trial were under the age of 30 and will likely need multiple replacement units over their lifetime.
“Now, we can tell you that instead of having three, four, five, six or seven old devices in your heart, when the battery dies, we can safely and seamlessly remove the old Aveir and put in a new one. ”
Hadadi said that given the success in MedStar Health's clinical trials, and now the FDA approval, they expect it to be only "a very short period of time until it's actually commercially available to our patients."