Virginia Tech researcher teams with FDA to advance device safety through numerical modeling
Rafael Davalos, the L. Preston Wade Professor in biomedical engineering and mechanics, is working with scientists at the U.S. Food and Drug Administration (FDA) to develop a numerical heart model as a regulatory science tool with applications in assessing cardiac ablation devices.
The team’s model will enable assessment of non-thermal ablation methods by simulating irreversible electroporation and comparing this approach to thermal damage effects on heart tissue in pulsed electric field cardiac ablation. The model will use quantifiable measurements of cell death and electrical properties of heart tissue, which will inform predictions of the size of the ablation zone for a particular set of ablation pulse parameters.
Cardiac ablation devices aim to terminate abnormal electrical signals in a heart, a phenomenon often observed in atrial fibrillation patients. Atrial fibrillation is a condition that causes an irregular and rapid heart rate due to chaotic electrical signals in the heart. Traditional cardiac ablation uses thermal energy to isolate the small area of heart tissue that is causing rapid and irregular heartbeats. When using thermal methods, applying heat or extreme cold, there is a risk of causing damage to surrounding tissue and organs, Davalos explained.
Non-thermal radiation, in contrast, can mitigate the risk of esophageal, nerve, and artery damage. Non-thermal, irreversible electroporation ablation devices use short but strong electrical fields to create permanent pores in heart cells and are currently under safety and effectiveness review by the Center for Devices and Radiological Health at the FDA.
In this project, the team will develop a first-of-its-kind, numerical irreversible electroporation ablation heart model. Davalos is working with Ksenia Blinova and Maura Casciola, who serve respectively as assistant director of biomedical physics and staff fellow at the FDA’s Office of Science and Engineering Laboratories, to develop the numerical, three-dimensional heart model.
Davalos believes the model will enable researchers to synergistically create a tool to inform regulators, as more advancements are made in the field using irreversible electroporation to treat atrial fibrillation.
“Irreversible electroporation for cardiac ablation could help thousands of lives,” said Davalos. “It is important to understand and characterize how the fields affect the tissue. The methods we have developed at Virginia Tech are state of the art and can help facilitate this. This collaboration will further that understanding, and I’m thrilled to be part of a team advancing this knowledge.”
Davalos directs research in the Bioelectromechanical Systems Laboratory, where he uses electrical feedback to perform complex procedures in biotechnology with precision and control, in addition to developing technology for tissue viability detection.
“This collaboration is a great application for this technology,” said Anand Vadlamani, postdoctoral research associate in Davalos’ lab. “Combining the expertise of the co-inventor of irreversible electroporation – Davalos – and the FDA’s in cardiac electrophysiology models results in the real possibility of saving more lives. That is part of what makes this research so incredible.”
According to the FDA, the model has the potential to decrease clinical and animal testing in irreversible electroporation ablation device development, inform the FDA regulatory review process and ultimately help atrial fibrillation patients with irregular heartbeats have access to innovative, safe, and effective devices.
“FDA has had a long-standing commitment to advancing alternative approaches in regulatory review, and the potential that modern technologies such as human cell-based assays and in silico modeling bring in the effort to replace, reduce, and refine animal testing is very exciting to us,” said Blinova.
The unique framework for the team’s multidisciplinary, inter-laboratory research collaboration was established through National Science Foundation/Food and Drug Administration Scholar-in-Residence Program at FDA, which comprises an interagency partnership for the investigation of scientific and engineering issues concerning emerging trends in medical devices technology, as described by the FDA. The partnership is designed to enable investigators in science, engineering, and computer science to develop research collaborations within the intramural research environment at the FDA.