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In only a couple of weeks after presenting the favorable findings of a study of its Aveir DR dual-chamber leadless pacemaker device, Abbott has received approval from the FDA for the technology. The firm stated that the data had been immediately submitted for regulatory evaluation.
The Aveir DR implant, like other leadless pacemakers before it, is an alternative option for those with irregular or sluggish heartbeats to help maintain a normal rhythm. These types of pacemakers are not only smaller than those that preceded them, but they also eliminate the need for the tiny wires that link traditional pacemakers, which are implanted around the collarbone, to the heart.
However, in contrast to the previous similar pacemakers that have been granted approval by the FDA up until this point, Abbott’s newly approved device enables the simultaneous use of two of the tiny implants. This is a significant improvement and enables it to better serve individuals who need pacing across two chambers of the heart, a group that, as per Abbott, accounts for over 80% of the population that requires pacemakers.
With the approval of the FDA, clinicians will now be allowed to insert a couple of single-chamber devices and link them via Abbott’s i2i communication technology. This was previously not possible. The Aveir DR system is a combination of two devices: the previously accepted Aveir VR device, which is put in the right ventricle (similar to other leadless pacemakers available on the market), and the smaller-sized Aveir AR device, which is meant to help pace the right atrium.
More About the New Leadless Pacemaker System
- Each pacemaker is no larger than a AAA battery.
- The pacemakers are placed in the appropriate chamber of the heart using minimally invasive techniques.
- They are attached to the internal surface of the heart using a mechanism that, according to the company that made them, enables simple recovery in the event that they need to be replaced or removed in the future.
- After the pacemakers have been implanted, the i2i technology employs high-frequency pulses to convey beat-to-beat data via the blood between the pair of devices. This enables the devices to perform either completely coordinated pacing or a different kind of synchronized rhythm.
Randel Woodgrift, senior VP of cardiac rhythm business at Abbott, stated, “Leadless pacemakers have been limited to a single-chamber device because seamless, wireless synchronization of two pacemakers has been an insurmountable engineering challenge—until now.”
Abbott claimed that the Aveir DR system had fulfilled all of its safety and effectiveness endpoints among the first 300 individuals in a clinical trial – this was when the company presented the research results at the annual conference of the Heart Rhythm Society in May.
More than 98% of the implants succeeded, and nearly as many individuals (97%), had normal heartbeats in both the upper and lower chambers of their hearts (a phenomenon known as “atrioventricular synchrony”) within the initial three months after implantation. According to Abbott, they also maintained this synchronization across a range of positions and walking speeds with an impressive success rate of 95%.
Read More: About Medical Devices