Jesse Heitke has been in the industry for over 14 years focused on medical devices specifically in these therapeutic areas: Coronary and peripheral drug coated balloons, coronary and peripheral stents, cardiac ablations (RF, cryotherapy, and PFA technologies), percutaneous ventricular assist devices, neuromodulation (deep brain, spinal, and peripheral stimulation), left atrial occluder devices, atrial shunts, arterial and venous peripheral occluder devices, vascular closure devices, ISO 10993-4 compliant thrombogenicity studies.
Jesse started out in the industry as an animal care technician at NAMSA (previously American Preclinical Services). He later moved into a Study Coordination role prior to becoming a Study Director, which he has been for over 10 years. Jesse has ran over 400 preclinical large animal studies, including over 150 GLP studies. These studies have covered a wide breadth of device types from cardiovascular, peripheral intervention, gastrointestinal, pulmonary, and neuromodulation.
Jesse is a graduate of the University of Minnesota – Twin Cities with a Bachelor’s in Animal Science with an emphasis in Dairy Production Systems Management and has received his Laboratory Animal Technician certification from AALAS. He is currently working towards his Project Management Professional certification.
CORE COMPETENCIES
- Preclinical study development and execution
- Animal model development
- Exceptional interpersonal communication
- Project management
- Data analysis
- FDA regulation experience
- Leading cross-functional teams
RECENT PROJECTS
- Helped develop a piglet PDA model for a pediatric device from initial feasibility studies through execution of a successful GLP safety study
- Management of multiple concurrent GLP cardiac ablation studies including PFA and cryoablation therapies
- Assisted in leading a successful AAALAC International site visit, resulting in continued full accreditation
PUBLICATIONS
- Evaluation of the MYNX CONTROLTM VENOUS Vascular Closure Device in a Healthy Porcine Model. Florencia Lim, PhD, Anokhi Patel, Rene Cunanan, Jacky Au-Yeung, Jesse Heitke, Michael Benser, PhD, Paul Johnson. Western Atrial Fibrillation Symposium 2025
- Incorporating Assessment of Tissue Response, Local Effects, and Systemic Toxicity of Chronically Implanted Medical Devices/Materials into Pivotal Safety and Performance Assessment Studies in Large Animals. Yan Chen, Jesse Heitke, Werner Hafelfinger, Mark Smith. Society of Toxicology Annual Meeting, 2018.
- Assessment of Thrombogenicity of the CardioGard Emboli Protection Cannula Gen2 in a Fully Anticoagulated Swine Cardiopulmonary Bypass Model. J. Heitke, D. Post, Y. Chen, T. van Valkenburg, M. Beckel, and M. Smith. Society of Toxicology Annual Meeting, 2019.
