The first U.S. commercial cases have been completed with the Abbott
(NYSE: ABT)
Aveir dual-chamber leadless pacemaker technology.
Abbott announced in July that it received FDA approval for the Aveir system. The approval marked the first such nod for a dual-chamber leadless pacing system for treating abnormal or slow heart rhythms.
According to Abbott, more than 80% of people who need a pacemaker require pacing in two chambers of the heart — the right atrium and right ventricle.
The system was included in Time magazine’s recent list of 2023’s best inventions. Matthew Fishler, the lead engineer on the Abbott Aveir project, explained how the company developed the system earlier this year.
Now, the commercially available system has been implanted in patients in the U.S. Dr. Rajesh Banker performed one implant at Hoag Memorial Hospital Presbyterian in Newport Beach, California.
“This advanced technology is a game-changer for cardiac patients. It is an exciting opportunity to provide our patients with access to groundbreaking technology as soon as it becomes widely available,” said Banker. “I am proud to work at a hospital that supports specialists like me with the resources to conduct leading-edge research and to offer cutting-edge technology that advances medicine and improves patient care.”
Another procedure took place at MedStar Washington Hospital Center in Washington, D.C.
“The leadless dual-chamber pacemaker is an excellent option to treat abnormally slow heart rates,” said Dr. Cyrus Hadadi, associate director of Cardiac Arrhythmia Research at MedStar Washington Hospital Center. “There are no wires implanted in veins, no metal device under the skin, and no surgical incision. This means the potential for less risk, greater comfort, and fewer post-procedure restrictions.”
More about the Abbott Aveir system
Abbott designed Aveir with its proprietary i2i communication technology. This helps to provide synchronized or coordinated cardiac pacing between two leadless pacemakers based on clinical needs.
The company developed the i2i technology to utilize high-frequency pulses, relaying messages through the naturally conductive characteristics of the body’s blood between each leadless pacemaker.
To support dual-chamber therapy, each implant communicates beat-to-beat with a paired, co-implanted device. The conductive communication uses far less batter current than inductive, radiofrequency or Bluetooth communication, Abbott said.
Two devices comprise Aveir DR, which comes in at roughly one-tenth the size of a traditional pacemaker (smaller than a AAA battery). Those devices — Aveir VR for the right ventricle and Aveir AR for the right atrium — incorporate the i2i technology.
With this approach, beat-to-beat communication between the leadless pacemakers solves a significant engineering challenge, Abbott explained. It also provides real-time pacing analysis so physicians can assess the proper device placement during the procedure.
Leadless pacemakers are implanted directly into the heart through a minimally invasive procedure, eliminating the need for cardiac leads. This method reduces exposure to potential lead and infection-related complications. It also results in a less restrictive and shorter recovery period post-implant.
Earlier this year, MassDevice recently spoke with Dr. Leonard Ganz about Abbott’s cardiac rhythm management efforts. READ HERE.