SC CTSI-Supported Researchers Develop First Fully-Implantable Micropacemaker Designed for Fetal Use
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, and the micropacemaker has been designated a Humanitarian Use Device by the US 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, MD, pediatric cardiologist at CHLA and lead author on the paper. “We have lacked an effective treatment option for fetuses.”
This article is written by Children's Hospital Los Angeles. For more information, please click here for details on this story.
Point Person Project: Creating a National Patient Recruitment System
Jonathan M. Davis, MD, Professor of Medicine, Tufts University School of Medicine, faced a problem – recruiting patients for pediatric clinical trials was proving to be quite challenging and studies were feeling the effect of low enrollment.
“Studies were having a hard time getting off the ground,” says Davis. “One company worked for two years to enroll patients in a study at multiple sites and recruited only three subjects. We thought, why don’t we try something simple? Let’s identify someone at each site to help,” says Davis.
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