News | Pacemakers | June 09, 2016

New Data Further Demonstrate Safety Benefits for Medtronic’s Micra Pacemaker

Data featured in late-breaking trial session at Cardiostim 2016 show Micra TPS safety benefits maintained beyond six months

Medtronic, Micra TPS pacemaker, Global Clinical Trial, Cardiostim 2016

June 9, 2016 — Medtronic plc announced new results from the Medtronic Micra Transcatheter Pacing System (TPS) Global Clinical Trial in a late-breaking trial session at CardioStim/EHRA EUROPACE 2016, the World Congress in Electrophysiology and Cardiac Techniques, in Nice, France.

The new follow-up data on patients enrolled in the pre-market Micra TPS Global Clinical Trial underscore the safety benefits of the Micra TPS, with only 3.7 percent of patients (27 of 726; Kaplan-Meier estimate) experiencing a major complication, and no patients (0) experiencing a device dislodgement at 7.7 months of follow-up.

The results showed that at 7.7 months, the risk for major complications with Micra is significantly lower — 52 percent — than the risk associated with conventional pacing systems (hazard ratio: 0.48; 95 percent CI, 0.32 to 0.72; P<0.001). In addition, the risk for major complications was lower for the Micra TPS relative to conventional systems across all patient sub-groups, whether measured by age, sex or comorbidity (all hazard ratios < 1.0).

"Clinicians are extremely pleased that the evidence continues to demonstrate the strong safety profile of the Micra for all patient groups," said Gabor Duray, M.D., head of clinical electrophysiology and pacing, State Health Center, Budapest, Hungary. "These data provide the largest sample and the longest follow-up reported for this technology to date. We look forward to further evaluating this minimally invasive, leadless option in patients across the world."

The Micra TPS is less than one-tenth the size of traditional pacemakers and the only leadless pacemaker approved for use in both the United States and Europe.  It is attached to the heart with small tines and delivers electrical impulses that pace the heart through an electrode at the end of the device. Unlike traditional pacemakers, the Micra TPS does not require leads or a surgical "pocket" under the skin, so potential sources of complications related to such leads and pocket are eliminated-as are any visible signs of the device.

At 7.7 months, Micra TPS continued to provide low and stable pacing thresholds, yielding projected average longevity for the device of more than 12 years based on device use conditions through six months on 590 patients. This longevity rate is similar to conventional pacing systems (references Hauser, et al Heart Rhythm 2007 and Senaratne, et al PACE 2006).

In November 2015, preliminary results from the Medtronic Micra TPS Global Clinical Trial were published in the New England Journal of Medicine and presented during a late-breaking Special Report at the American Heart Association Scientific Sessions. Data showed the Micra TPS was successfully implanted in 99.2 percent of patients and the system met its safety and effectiveness endpoints with wide margins. Data from beyond six months, presented at Cardiostim 2016, reinforced these results with no (0) dislodgments and no (0) systemic infections. These low complication rates were achieved despite the inclusion of high-risk patients in the study worldwide, including patients with chronic obstructive pulmonary disease (COPD).

Micra's design incorporates a retrieval feature to enable retrieval when possible; however, the device is designed to be left in the body. For patients who need more than one device, the miniaturized Micra TPS was designed with a 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 device was awarded CE Mark in April 2015 and U.S. Food and Drug Administration (FDA) approval in April 2016. It is intended for use in patients who need a single-chamber pacemaker. According to Medtronic, Micra is the first and only leadless pacing system to be approved for both 1.5 and 3 Tesla (T) full-body magnetic resonance imaging (MRI) scans, providing patients with access to the most advanced imaging diagnostic procedures available. The device was designed to allow patients to be followed by their physicians and send data remotely via the Medtronic CareLink Network; remote monitoring of Micra devices is expected to be available later this year.

For more information: www.medtronic.com

Related Content

Hershey's Chocolate display with samples and coco pods at the American College of Cardiology (ACC) 2012 annual meeting. The company was making the case that chocolate can be good for your heart, which is now supported by several studies. Photo by Dave Fornell

Hershey's Chocolate display with samples and coco pods at the American College of Cardiology (ACC) 2012 annual meeting. The company was making the case that chocolate can be good for your heart, which is now supported by several studies. Photo by Dave Fornell

News | Cardiovascular Clinical Studies | July 22, 2020
July 22, 2020 — Eating chocolate at least once a week is linked with a reduced risk of heart disease, according to re
The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

News | Cardiovascular Clinical Studies | January 20, 2020
January 20, 2020 — Scientists at Los Alamos and international partners have created the first 3-D images of a special
Top Cardiology New in 2019 From the European Society of Cardioloigy (ESC)
News | Cardiovascular Clinical Studies | December 23, 2019
Environmental and lifestyle issues were popular this year, with pick up from both...
News | Cardiovascular Clinical Studies | November 26, 2019
November 26, 2019 — The University of Connecticut (UConn) Department of Kinesiology and Hartford Healthcare have sele
FDA Issues Final Guidance on Live Case Presentations During IDE Clinical Trials
News | Cardiovascular Clinical Studies | July 10, 2019
The U.S. Food and Drug Administration (FDA) issued the final guidance “Live Case Presentations During Investigational...
Veradigm Partners With American College of Cardiology on Next-generation Research Registries
News | Cardiovascular Clinical Studies | July 03, 2019
The American College of Cardiology (ACC) has partnered with Veradigm, an Allscripts business unit, to power the next...
New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp