Virginia Tech researcher teams with FDA to advance device safety through numerical modeling | VTx

“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.

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