BOSTON--(BUSINESS WIRE)--AVS (Amplitude Vascular Systems, Inc), an early-stage medical device company focused on safely and effectively treating severely calcified arterial disease with its PIVL™ therapy, announced the appointment of Elizabeth Galle as the company’s new Vice President of Clinical Affairs. She comes to AVS with more than two decades of leadership experience in the device space, most recently serving as the 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,” said Mark Toland, Chairman of the Board of AVS. “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 as the Vice President of Global Clinical Research 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 oversaw 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.”
At the recent TCT 2024 conference, AVS presented positive first in human data that supported the safety and efficacy of pulse intravascular lithotripsy. This momentum sets the stage for further groundbreaking research in calcium modification.
About AVS
AVS is an early-stage medical device company focused on safely and effectively treating severely calcified arterial disease. It is redefining interventional therapy for severely calcified lesions with the Pulse™ IVL System, which uses a novel pulsatile mechanism of action to shatter calcium and expand narrowed vessels, all with a single device. To learn more about pulsatile intravascular lithotripsy, visit www.avspulse.com.
The Pulse Peripheral Intravascular Lithotripsy (IVL) System is in development. It is not yet cleared for commercial distribution in any country. Its future availability cannot be guaranteed.
