The Georgia Clinical & Translational Science Alliance- Georgia CTSA and Southern California Clinical and Translational Science Institute -SC-CTSI have collaborated to provide free, high quality educational programs for clinical research professionals at novice to expert levels of experience. At the completion of each course or program, participants earn contact hours recognized by a certificate and/or badge.

Description:

Complete heart block in the preterm fetus is a life-threatening emergency with no effective treatment options beyond watchful waiting or preterm delivery. More than a quarter of these fetuses do not survive.  The design, development, engineering, testing, and implantation of a fetal micropacemaker for advanced fetal surgical intervention will be discussed.

Topics:

1. Regulatory Pathways for Class III Medical Devices
2. A Rare but Fatal Problem: Fetal Heart Block
3. Minimally Invasive Fetal Pacemaker and its Challenges:
   • Implantation
   • Pacing
   • Survival such as motion, integrity, charging, etc.
4. Fabrication and Deployment of a Minimally Invasive Fetal Pacemaker:
5. Current Cardiac Pacing Challenges:
   • Adult Pacing – Intravascular Lead
   • Pediatric Pacing – Epicardial Lead

Speaker: 

Gerald E. Loeb, MD received his BA and MD degrees from Johns Hopkins University and trained in surgery before joining the U.S. National Institutes of Health as an intramural neuroscientist (1973-88).  He was Professor of Physiology and Director of Biomedical Engineering at Queen’s University (1988-99) and has been at the University of Southern California since 1999 with adjunct appointments in Neurology and Pharmacy.  Dr. Loeb directs the Medical Device Development Facility at USC and is Deputy Director of the National Science Foundation Engineering Research Center for Biomimetic MicroElectronic Systems.  Dr. Loeb has published over 200 journal articles and holds 47 U.S. patents, including key components of commercialized medical products including injectable RFID tags, cochlear implants, spinal cord stimulators, BION neuromuscular stimulators and several types of neurophysiological electrodes.  He was Chief Scientist of Advanced Bionics Corp. (1994-1999) and is now President of Biomed Concepts Inc., a consulting and prototyping company, and CEO of SynTouch LLC, developers of tactile sensors for prosthetic and robotic limbs.  He was selected as one of Medical Device & Diagnostic Industry Magazine’s 100 Notable People in the Medical Device Industry.  gloeb@bmsr.usc.edu

Learner Level: Advanced

Audience:

This course is designed for Clinical Research Coordinators, Project Managers, Monitors, Regulatory, Medical and Clinical Affairs Professionals or junior faculty with 3+ years of experience seeking to further develop clinical research conduct skills and principles.  Clinical research professionals should have responsibilities that include clinical trial start up planning, mentoring and complex issues involving site management, study management, and sponsor/ CRO challenges. 

Contact Hours:

Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of nursing continuing professional development by the American Credentialing Center’s Commission on Accreditation. Attendees to this CNE activity will be awarded 1.0 contact hours by ENPDC. No conflict of interest has been found with the speaker for this CNE activity nor with the members of the planning committee.

Need Help with Registration? Please contact us at ene@emory.edu or 404-727-9208.

Program Information: This is the sixth course in a six (6) session program. To complete the entire program and earn a badge CLICK HERE.