News | May 11, 2015

Medtronic Announces CE Mark for World’s Smallest Pacemaker

Miniaturized device less than one-tenth the size of a conventional pacemaker and placed directly in the heart

Medtronic, Micra TPS, pacemaker, world's smallest, CE Mark

May 11, 2015 — Medtronic plc announced it has received CE (Conformité Européenne) Mark for the Micra Transcatheter Pacing System (TPS), the world’s smallest pacemaker. At less than one-tenth the size of traditional pacemakers, the Micra device provides advanced pacing technology while being cosmetically invisible and small enough to be delivered with minimally invasive techniques through a catheter, and implanted directly into the heart.

Comparable in size to a large vitamin, the Micra TPS does not require the use of 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.  

“Unlike traditional pacemakers, the Micra TPS does not require leads or a surgical ‘pocket’ under the skin, so potential sources of complications are eliminated – as are any visible signs of the device,” said Philippe Ritter, M.D., cardiologist at Hôpital Cardiologique de Haut Lévêque and Centre Hospitalier Universitaire (CHU) Bordeaux. “While the Micra TPS is dramatically smaller, it is a fully self-contained pacemaker that still delivers the most advanced pacing technology available to patients.”

Once positioned, the Micra TPS is attached to the heart wall and can be repositioned or retrieved if needed. The device responds to patients’ activity levels by automatically adjusting therapy. Despite its miniaturized size, the Micra TPS has an estimated 10-year battery life and is approved for full-body magnetic resonance imaging (MRI) scans, providing patients with access to the most advanced imaging diagnostic procedures.

The device was awarded CE Mark based on results from the first 60 patients (at three months) in the Medtronic Micra TPS Global Clinical Trial. The trial is ongoing and will continue to evaluate the safety and efficacy of the device through a single-arm, multi-center study that will enroll up to 780 patients at approximately 50 centers in 20 countries. Initial results from the trial will be revealed for the first time at a late-breaking clinical trials session at the Heart Rhythm Society’s 2015 Annual Scientific Sessions, May 13-16 in Boston.

In the U.S., the Micra TPS is an investigational device and not yet approved for commercial use.

For more information: www.medtronic.com

Related Content

CHLA/USC Team Designs Novel Micropacemaker

Model of the human heart with microprocessor located in the pericardial sac and attached to the left ventricle. Graphic courtesy of Business Wire.

News | Pacemakers | June 29, 2018
Investigators at Children's Hospital Los Angeles (CHLA) and the University of Southern California (USC) have...
Permanent Pacing Effective for Older Patients With Syncope and Bifascicular Block
News | Pacemakers | May 24, 2018
Syncope with bifascicular block may be caused by intermittent complete heart block, but competing diagnoses may coexist...
Novel Mechanical Sensor in Medtronic Micra Transcatheter Pacing System Detects Atrial Contractions, Restores AV Synchrony
News | Pacemakers | May 24, 2018
New clinical study results demonstrate that an investigational algorithm, utilizing the accelerometer signal in the...
The Boston Scientific Essentio MRI-safe pacemaker.

The Boston Scientific Essentio MRI-safe pacemaker. It is common for pacemaker patients to need magnetic resonance imaging (MRI), which has not previously been possible because the magnetic fields could damage older devices. All pacemaker vendors now have FDA-cleared MRI compatible pacemakers. 

Feature | Pacemakers | February 13, 2018 | Dave Fornell
There have been several advancements in pacemaker technologies over the past few years.
Mexican Doctors Safely Reuse Donated Pacemakers After Sterilization

Mexican government reports conclude more than half of the population does not have access to social security or private insurance that covers a pacemaker implant, and 44 percent live in poverty. Recycling donated, explanted pacemakers offers a new option for these patients.

News | Pacemakers | November 10, 2017
Mexican doctors have safely reused donated pacemakers after sterilization, shows a study presented at the 30th Mexican...
Pacemakers and Other Cardiac Devices Can Help Solve Forensic Cases
News | Pacemakers | June 20, 2017
Pacemakers and other cardiac devices can help solve forensic cases, according to a study presented at the European...
Videos | Pacemakers | May 23, 2017
Vivek Reddy, M.D., director of cardiac arrhythmia services and professor of medicine, cardiology, Mount Sinai Hospita
micra leadless pacemaker
Feature | Pacemakers | May 16, 2017
May 16, 2017 - The preliminary results for the Medtronic Micra Transcatheter Pacing System (TPS) Post-Approval Regist
Videos | Pacemakers | May 16, 2017
This video, provided by Medtronic, demonstrates the implantation of Micra transcatheter pacing system (TPS).
closed loop stimulation, DDD-CLS, ACC17, SPAIN trial
Feature | Pacemakers | March 22, 2017
March 22, 2017 — Patients with recurrent fainting episodes (syncope) who received a pacemaker delivering a pacing pro
Overlay Init