Elizabeth Galle Named Clinical Affairs VP at AVS

AVS (Amplitude Vascular Systems Inc) has appointed Elizabeth Galle as vice president of Clinical Affairs. She has more than two decades of leadership experience in the medical device space, most recently serving as vice president of Global Clinical Research at CVRx.
 
“In a time of significant growth and innovation at AVS, we are excited to welcome Liz to our executive leadership team,” AVS Board Chairman Mark Toland said. “Her experience leading multi-functional clinical teams and steering new devices to the market will be invaluable as we approach multiple clinical and regulatory milestones for the PULSE IVL System.”
 
In her most recent role at CVRx, Galle led a global team throughout numerous clinical study activities, publications, and submissions to the U.S. Food and Drug Administration (FDA). She supervised the effective development of clinical strategies and their execution, while collaborating with key opinion leaders for clinical guidance, publications and future opportunities. Prior to CVRx, Galle was the senior clinical manager of clinical scientists and biostatisticians at Boston Scientific Corporation, where she supported the design and execution of a large portfolio of cardiovascular clinical studies. In her time there, she helped to execute numerous agreements with the FDA and other competent authorities, including two successful FDA panel-track submissions.
 
“AVS has emerged as a pioneer in an exciting and novel area in medicine, intravascular lithotripsy,” Galle said. “The team has already built significant clinical momentum with the success of the first-in-human peripheral vascular cases, and I look forward to helping to bring new solutions to the market for both peripheral and coronary therapy.”
 
Boston-based AVS is an early-stage medical device company focused on treating severely calcified arterial disease. It has developed an interventional therapy solution for severely calcified lesions with the Pulse IVL System, which uses a pulsatile mechanism of action to shatter calcium and expand narrowed vessels, all with a single device. 
 
The Pulse Peripheral Intravascular Lithotripsy (IVL) System is in development. It is not yet cleared for commercial distribution in any country.