Researchers in the USA have developed the first fully implantable micropacemaker designed for use in a foetus with complete heart block. The micropacemaker has been designated a humanitarian use device by the US Food and Drug Administration (FDA).
The team at the Children’s Hospital Los Angeles (CHLA) and the University of Southern California (USC), USA, has reported preclinical testing and optimisation in a recent issue of HeartRhythm.
“Up until now, the pacemaker devices that have been used in an attempt to treat this condition [congenital heart block] in a foetus were designed for adults,” says Yaniv Bar-Cohen, paediatric cardiologist at CHLA and lead author on the paper. “We have lacked an effective treatment option for foetuses.”
“We now have a pacemaker that can be implanted in utero, potentially without harm to the foetus or the mom,” says Ramen H Chmait, 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 foetus and the rest to remain externalised. This design has uniformly failed, likely due to foetal 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 foetus,” says Gerald E Loeb, professor of Biomedical Engineering at the Viterbi School of Engineering at USC. “This will allow the foetus to move freely without risk of dislodging the electrodes.”
The investigators anticipate the first human use of the device in the near future.