Bradycardia is a condition characterized by a slow or irregular heart rhythm, usually fewer than 60 beats per minute. At this rate, the heart is unable to pump enough oxygen-rich blood to the body during normal activity or exercise, causing dizziness, fatigue, shortness of breath or fainting spells. Pacemakers are the most common way to treat bradycardia to help restore the heart’s normal rhythm and relieve symptoms by sending electrical impulses to the heart to increase the heart rate.
Comparable in size to a large vitamin, this device is unlike traditional pacemakers in that it does not require cardiac wires (leads) or a surgical “pocket” under the skin to deliver a pacing therapy. Instead, the device is small enough to be delivered through a catheter and implanted directly into the heart with small tines, providing a safe alternative to conventional pacemakers without the complications associated with leads – all while being cosmetically invisible. It is also designed to automatically adjust pacing therapy based on a patient’s activity levels.
“Our goal is to bring the latest in technology to the people of East Texas,” states Dr. Mangla. “This particular pacemaker is approved for MRI scans and is designed to allow patients to be followed by their physicians and send data remotely, which are life-changing benefits.”
The pacemaker also incorporates a retrieval feature to enable retrieval of the device when possible; however, the device is designed to be left in the body. For patients who need more than one heart device, the miniaturized device was designed with a unique feature that enables it to be permanently turned off so it can remain in the body and a new device can be implanted without risk of electrical interaction.
It was approved by the U.S. Food and Drug Administration in April 2016, and has been granted Medicare reimbursement, allowing broad patient access to the novel pacing technology
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