Lake City Medical Center April 13, 2018

Miniaturized Heart Device Provides Patients with the Most Advanced Pacing Technology Available

Lake City, Fl — Today announced that it is one of the first hospitals in Florida to offer the world’s smallest pacemaker for patients with bradycardia. The miniature leadless 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 first procedure at was performed on Thursday April 12, 2018

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, physicians at Lake City Medical Center have elected to use the “Leadless” TPS because unlike traditional pacemakers, the device 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. The TPS is also designed to automatically adjust pacing therapy based on a patient’s activity levels.

The 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 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 TPS used at Lake City Medical Center 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.