Researchers at Children’s Hospital Los Angeles and the University of Southern California said the FDA granted humanitarian use device status to the fetal micro-pacemaker they designed.
The device is the 1st fully implantable pacemaker for use in a fetus with complete heart block, according to a press release. The 1st implantation in a human is expected "in the near future," the researchers said.
"Up until now, the pacemaker devices that have been used in an attempt to treat this condition in a fetus were designed for adults," Dr. Yaniv Bar-Cohen of CHLA said in prepared remarks. "We have lacked an effective treatment option for fetuses."
The problem with treating pre-nates with an adult-size device is that only a small part can be implanted in the fetus. This approach has "uniformly failed," the researchers said, most likely because the baby’s movement dislodged the pacemaker’s leads.
Dr. Gerald Loeb of USC’s Viterbi School of Engineering said the device was built using his lab’s experience with micro-fabrication to create medical devices.
"This will allow the fetus to move freely without risk of dislodging the electrodes," Loeb said.
"We now have a pacemaker that can be implanted in utero, potentially without harm to the fetus or the mom," Dr. Ramen Chmait of the CHLA-USC Institute for Maternal-Fetal Health said in a statement. "This novel device provides a real opportunity to prevent miscarriage and premature birth in babies affected with these abnormalities."
There are some 500 U.S. pregnancies annually affected by fetal heart block, according to the release. The research was funded by the National Institutes of Health, the Southern California Clinical & Translational Science Institute, the Wright Foundation and the Coulter Foundation, according to the release.