FDA Gives Fetal Micro-Pacemaker Humanitarian Exemption

The FDA has granted a humanitarian device exemption to the first fully implantable fetal micro-pacemaker for prenates. The device — designed by Children’s Hospital Los Angeles and University of Southern California researchers — will see its first human implantation in the near future, the researchers said Friday.

Previously, pacemakers used to treat fetal heart block were designed for adults. This is a problem because only a small part of the device can be implanted in the fetus and its movements almost certainly will cause pacemaker lead dislodgement, the researchers said. They noted this approach has repeatedly failed.

The pacemaker’s design incorporated Dr. Gerald Loeb of USC and his lab’s experience with medical device micro-fabrication, an innovation that will allow free movement in a fetus without risk of electrode dislodgement.

The device creates the potential to prevent miscarriages and premature births for those afflicted with fetal heart block — potentially without causing harm to the fetus or mother — Dr. Ramen Chmait of the CHLA-USC Institute of Maternal-Fetal Health added.
In the U.S., there are an estimated 500 fetal heart block pregnancies annually.

The NIH, the Southern California Clinical & Translational Science Institute, the Wright Foundation and the Coulter Foundation funded the research. — Jason Scott