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Understanding Clinical Trials
The Micra® Transcatheter Pacing System (TPS) is a new type of heart device, approved for Medicare reimbursement, that provides patients with the most advanced pacing technology at one-tenth the size of a traditional pacemaker.
"The availability of this new pacemaker technology represents yet another step forward toward the goal of being able to offer cutting edge cardiovascular care to patients who would otherwise be considered high-risk for traditional pacemaker implantation," said Cyrus Buhari, MD, the interventional cardiologist to implant the first Micra® pacemaker at St. Joseph's Heart & Vascular Institute.
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, the Micra® TPS is unlike traditional pacemakers because the device does not require cardiac wires (leads) or a surgical "pocket" under the skin to deliver a pacing therapy. The device is cosmetically invisible and it is small enough to be delivered through a catheter and implanted directly into the heart. It delivers electrical impulses that pace the heart, automatically adjusting pacing therapy based on a person's activity.
The Micra TPS 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 Micra TPS 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.
The Micra TPS is the first and only transcatheter pacing system to be approved for both 1.5 and 3 Tesla (T) full-body magnetic resonance imaging (MRI) scans and is designed to allow patients to be followed by their physicians and send data remotely via the Medtronic CareLink® Network.
The Micra TPS 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.