Feature | March 30, 2015

First Fully-Implantable Micropacemaker Designed for Fetal Use

Novel device has received Humanitarian Use Device designation from FDA

fetal pacemaker, CHLA, USC, first, fully implantable, FDA

Comparative sizes of fetal and adult pacemakers

March 30, 2015 — A team of investigators at Children’s Hospital Los Angeles and the University of Southern California have developed the first fully implantable micropacemaker designed for use in a fetus with complete heart block. The team has done preclinical testing and optimization as reported in a recent issue of the journal Heart Rhythm. The micropacemaker has been designated a Humanitarian Use Device by the U.S. Food & Drug Administration (FDA). The investigators anticipate the first human use of the device in the near future.

“Up until now, the pacemaker devices that have been used in an attempt to treat this condition in a fetus were designed for adults,” said Yaniv Bar-Cohen, M.D., pediatric cardiologist at CHLA and lead author on the paper. “We have lacked an effective treatment option for fetuses.”

With each beat of a healthy heart, an electrical signal moves from the upper to the lower chambers of the heart. As this signal moves, it results in the heart contracting and pumping blood. Congenital heart block is a defect of the heart’s electrical system that originates in the developing fetus, greatly slowing the rate of the heart and impacting its ability to pump blood. Although the condition can be diagnosed in utero, all attempts to treat the condition with a standard pacemaker have failed.

“We now have a pacemaker that can be implanted in utero, potentially without harm to the fetus or the mom,” said Ramen H. Chmait, M.D., director of the CHLA-USC Institute for Maternal-Fetal Health. “This novel device provides a real opportunity to prevent miscarriage and premature birth in babies affected with these abnormalities.”

The size of the adult device requires a small part to be implanted in the fetus and the rest to remain externalized. This design has uniformly failed, likely due to fetal movement causing the electrodes to become dislodged from the heart.

“Building on our experience of using microfabrication techniques to create biomedical devices, we have developed a micropacemaker small enough to reside entirely within the fetus,” said Gerald E. Loeb, M.D., professor of biomedical engineering at the Viterbi School of Engineering at USC. “This will allow the fetus to move freely without risk of dislodging the electrodes.”

Each year, approximately 500 pregnancies in the United States are affected by fetal heart block and could be candidates for receiving this device.

For more information: www.chla.org

Related Content

Results from the MARVEL 2 (Micra Atrial Tracking Using A Ventricular accELerometer) study shows that an investigational set of algorithms in the Medtronic Micra Transcatheter Pacing System (TPS) significantly improves synchrony and cardiac function in patients with atrioventricular (AV) block. This is an impaired electrical conduction between the chambers of the heart.
News | Pacemakers | November 15, 2019
November 15, 2019 — Results from the MARVEL 2 (Micra Atrial Tracking Using A Ventricular accELerometer) study shows t
Co-principal investigator professor Aydin Babakhani at the UCLA Integrated Sensor Laboratory holds an earlier version of the prototype leadless, wireless amnd batteryless pacemaker. Photo Credit: Cody Duty, Texas Medical Center.

Co-principal investigator professor Aydin Babakhani at the UCLA Integrated Sensor Laboratory holds an earlier version of the prototype leadless, wireless and battery-less pacemaker. Photo Credit: Cody Duty, Texas Medical Center.

News | Pacemakers | November 13, 2019
FDA Warns of Premature Battery Depletion in Some Medtronic Pacemakers
News | Pacemakers | May 07, 2019 | Dave Fornell, Editor
The U.S. Food and Drug Administration (FDA) issued a safety communication to alert healthcare providers and patients...
Artificial Intelligence Can Improve Emergency X-ray Identification of Pacemakers
News | Pacemakers | March 29, 2019
A research team from Imperial College London believes a new software could speed up the diagnosis and treatment of...
Medtronic Recalls Dual Chamber Pacemakers
News | Pacemakers | February 20, 2019
Medtronic is recalling its dual chamber implantable pulse generators (IPGs) due to the possibility of a software error...
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 pac...
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...
Overlay Init