Article source: Heart Future; Edited by Jacky
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On July 5, 2023, Abbott (NYSE: ABT) announced that its AVEIR™ DR™ leadless pacemaker system has been approved by the U.S. Food and Drug Administration (FDA).
# The AVEIR™ dual-chamber leadless pacemaker was approved by the FDA
AVEIR™ DR is the world's first dual-chamber leadless pacemaker system for the treatment of patients with abnormal or slow heart rhythms. More than 80 percent of pacemakers require pacing in two ventricles (right atrium and right ventricle), so this FDA approval improves access to leadless pacemaker treatment for millions of people across the United States.
The AVEIR DR leadless pacemaker system is about one-tenth the size of a conventional pacemaker and consists of two devices, the previously FDA-approved AVEIR VR single-chamber pacemaker for right ventricular pacing and the just-approved AVEIR AR single-chamber pacemaker for right atrial pacing.
The AVEIR DR pacemaker system uses Abbott's innovative i2i (implant-to-implant) technology. This is an interconnected technology between pacemakers that allows two wireless pacemakers to communicate and coordinate with each other to ensure that the heart is properly paced to meet major engineering challenges.
▲The picture comes from the company's official website (the same below)
The AVEIR DR system uses Abbott's patented i2i™ interconnect technology to provide synchronized or coordinated cardiac pacing between two leadless pacemakers based on the patient's clinical needs. This technology uses high-frequency pulses to transmit signals through the natural conduction properties of human blood between wireless pacemakers.
To support dual-chamber pacemaker therapy, the implanted pacemaker communicates beat-by-beat with a co-implanted pacemaker paired with it. This connected real-time communication is critical because the system uses much less battery current than inductive, RF, or Bluetooth communications, which are primarily used in implantable medical devices or traditional pacemakers.
Unlike traditional pacemakers, wireless systems are implanted directly into the patient's heart through minimally invasive surgery, eliminating the need for heart leads. As a result, leadless pacemakers reduce the patient's chances of potential lead infection and related complications, with fewer surgical restrictions and a shorter postimplantation recovery period.
# The AVEIR™ system represents a breakthrough in medical technology
The AVEIR DR dual-chamber leadless pacemaker system was supported by extensive research prior to FDA approval. A recent article published in the New England Journal of Medicine provides the latest clinical data showing that the AVEIR DR System has met three pre-set primary goals to demonstrate product safety and efficacy.
IDE studies with AVEIR DR i2i technology showed a 98.3% success rate for implantation three months after surgery, with more than 97% of patients successfully achieving atrioventricular synchronous pacing. Therefore, although there are different types of slow rhythms present in the heart itself, the atria ventricular beat is normal.
Randel Woodgrift, senior vice president of Abbott's heart rhythm management business, said wireless pacemakers have long been limited to single-chamber devices because achieving seamless, wireless synchronous pacing of two pacemakers is an insurmountable engineering challenge. Abbott's team of scientists and engineers has developed this powerful miniature AVEIR pacemaker system that solves this complex medical technology challenge in treating abnormal heart rhythms.
# About the AVEIR™ DR pacemaker
(1) Introduction to the system
AVEIR PACEMAKERS ARE SHORTER, SMALLER AND THINNER THAN AA BATTERIES AND ARE IMPLANTED THROUGH MINIMALLY INVASIVE SURGERY. The system is attached to the inner surface of the heart by a threaded fixation mechanism to secure the pacemaker in the heart tissue, and the device can be removed if a change in treatment is required, or if the system is to be replaced in the future. In addition, the AVEIR DR system is designed to provide real-time pacing analysis, allowing physicians to assess the correct placement of the device before implanting it inside the ventricle during surgery.
(2) System advantages
1. The leadless AVEIR™ DR system offers all the clinical benefits of a traditional dual-chamber pacemaker without complications associated with pacemaker leads and implant bags, including infection, lead dislocation, insulation problems, skin erosion, scarring, or mobility limitations.
2. The beat-by-beat communication AVEIR DR leadless pacemaker system combines an atrial leadless pacemaker (AVEIR AR LP) and a ventricular leadless pacemaker (AVEIR™™™ VR LP) capable of pacing and sensing simultaneously in the atria and ventricles. Industry-first patented I2I™ technology enables leadless synchronous pacing between the atria and ventricles.
3. Upgradeable system surgeons can customize treatment modalities for patients, either by implanting a single atrial or ventricular pacemaker, or by implanting two simultaneously to support dual-chamber pacing. Over time, the upgradeable system allows physicians to meet the patient's current needs and adjust to later disease progression.
4. Can be removed for a long time Because the pacemaker needs to be replaced, repaired or other reasons, the doctor may need to remove the pacemaker from the patient's body at some point or situation in the future. The AVEIR™ DR system supports the replacement of the pacemaker of the atrium or ventricle at the end of service without leaving any hardware in the patient's body.
Long-term removal of the AVEIR™ VR Ventricular Leadless Pacemaker predevice has a success rate of over 88% and spiral fixation for up to 9 years, regardless of the length of implantation. Custom-designed catheters provide additional assurance and support step-by-step removal. The AVEIR™ system is designed with active fixation using a threaded fixation mechanism to enable atrial and ventricular pacemaker implantation and long-term removal.
# About Abbott
Abbott Abbott (NYSE: ABT) is a global healthcare company founded in 1888 and headquartered in Chicago, USA. After a century of development, the company has now become a Fortune 500 company with diversified pharmaceutical and nutritional products. In the 2022 Forbes Global 2000, Abbott ranked 134th.
Abbott operates in more than 160 countries and regions around the world, employs nearly 110,000 people, and its products involve nutrition, drugs, medical devices, diagnostic instruments and reagents.
On January 25, 2023, Abbott announced its fourth-quarter results: Abbott's full-year 2022 revenue of $43.7 billion, +1.3% year-on-year; Organic growth +6.4%. Among them, the revenue of medical devices was 14.687 billion US dollars, and the revenue of medical devices in the cardiovascular field in 2022 was 9.161 billion US dollars.