VP Clinical, Regulatory, Quality
MicroTransponder Inc.
I have lead industry-sponsored studies for 30+ years, including VNS for epilepsy and depression, and Paired VNS for upper limb recovery after stroke.
I have more than 30 years of experience in medical device development, focused on human clinical trials of these types of devices. Much of my experience was at Cyberonics (14 separate clinical trials in 11 countries over 19 years), focused specifically on implantable neurostimulation devices for vagus nerve stimulation. I also have significant experience with Paired VNS for upper limb improvement after stroke, which was approved in the U.S. in August 2021 (P210007). I served as Study Director overseeing all aspects of the study and negotiating regulatory approval with FDA; I have worked on this since 2010. I currently oversee our Vivistim GRASP Registry (registry for commercial implants) and At-Home Study (study to assess Paired VNS provided by in-home therapists).
In total, I have been involved in IDE submissions for over 10 neurostimulation indications. I have been involved in all aspects of investigational studies – from design of the studies, to writing various required sections, to discussing and negotiating the IDE with FDA. I also managed Cyberonics’ pilot (3 sites, 10 patients) and pivotal (10 sites, 115 patients and 20 sites, 200 patients) studies of VNS for epilepsy from start to finish, and was heavily involved in the required submissions to FDA that ultimately lead to commercial approval. I was also involved in an advisory capacity in the pilot and pivotal acute phase of Cyberonics VNS depression studies; when the pivotal study had difficulties, I was moved into direct management responsibility for the trial. We successfully completed the study and received FDA approval for the depression indication for VNS.
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