Study conducted at the Minneapolis Heart Institute Foundation finds World's Small Pacemaker meets initial Safety and Performance Measures
Minneapolis, MN, First-of-its-kind results
from a groundbreaking clinical trial conducted at the Minneapolis Heart
Institute Foundation were revealed at a major medical conference this month. The
study, which is evaluating
the world’s smallest pacemaker, was presented at the Heart Rhythm Society’s 36th Annual
Scientific Sessions, and results showed that the miniaturized Micra®Transcatheter Pacing System
(TPS) has met its initial safety and performance measures: 100 percent of
the first 140 patients who received the Micra TPS experienced a successful
implant procedure.
“These initial findings are encouraging and we are pleased to be among the participating clinical trial sites evaluating this novel pacemaker,” said Charles C. Gornick, MD, physician at Minneapolis Heart Institute® at Abbott Northwestern Hospital, one of the initial institutions in the world participating in this study. “This miniaturized transcatheter pacemaker – which is about the size of a large vitamin -- may prove to be a simpler and less-invasive pacemaker option for many patients.”
Patients evaluated in this study spanned a wide variety of profiles, including ages ranging from 21 to 94 years, weights ranging from 90 – 362 pounds and global residency including Asia-Pacific, Europe and the U.S. The study also included high-risk patients with lung disease such as COPD (chronic obstructive pulmonary disease) and pulmonary hypertension. Of the 140 patients, who were followed for an average of two months, only two patients (1.4 percent) experienced events which resulted in prolonged hospitalization, which is in line with rates observed in studies of traditional pacemakers.
At less than one-tenth the size of traditional pacemakers, the Micra TPS provides the most advanced pacing technology available while being cosmetically invisible. It is small enough to be delivered through a tube, or catheter, which is inserted in the upper leg, threaded to the heart and then implanted directly inside the heart.
U.S. enrollment began in February 2014 and ended in April 2015. The Minneapolis Heart Institute Foundation was the 5th highest enrolling site in the U.S. with a total 17 enrollments between Abbott Northwestern Hospital, Mercy Hospital and United Hospital (9 at Abbott Northwestern Hospital, 6 at Mercy Hospital, 2 at United Hospital). Charles C. Gornick, MD, Stephen Remole, MD and Pierce Vatterott, MD are the implanting cardiologists with Kate Schmitt, Brittany Renier, and Sarah Clarke as the lead research coordinators for this study.
The Micra TPS does not require the use of wires, known as “leads,” to deliver pacing therapy; rather, it is attached to the heart via small tines and delivers electrical impulses that pace the heart through an electrode at the end of the device. Once positioned, the Micra TPS can be repositioned or retrieved, if needed. The device responds to patients’ activity levels by automatically adjusting therapy. Unlike traditional pacemakers, the Micra TPS does not require a surgical “pocket” under the skin, so potential sources of complications are eliminated—as are any visible signs of the device.
About the Medtronic Micra TPS
In the United States, the Micra TPS is an investigational device and not yet approved for commercial use. The Medtronic Micra TPS Global Clinical Trial is ongoing and will continue to evaluate the safety and effectiveness of the device through a single-arm, multi-center study that has enrolled more than 700 patients at 56 centers in 19 countries.
Source: Minneapolis Heart Institute Foundation® and Minneapolis Heart Institute®
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