FDA Approves AVS for Crucial Intravascular Lithotripsy Study

Friday, June 07, 2024

Amplitude Vascular Systems (AVS), a medical device company specializing in treating severely calcified arterial disease, announced today that it has received an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) to commence its pivotal trial for pulsatile intravascular lithotripsy (PIVL) therapy.

This trial, named POWER-PAD-II, aims to evaluate the safety and efficacy of AVS’s Pulse IVL™ System for treating patients with severely calcified peripheral arterial disease in the United States. Up to 120 subjects will be enrolled and followed for up to six months.

This follows the successful POWER-PAD-I trial, presented by Dr. Jon George at TCT in October 2023, which demonstrated clear benefits for patients with calcific femoropopliteal arteries.

The first companies to conduct a pivotal IDE trial for peripheral intravascular lithotripsy in the US.

He highlighted the IDE approval as a significant clinical milestone, bringing AVS closer to FDA clearance and market availability for the Pulse IVL™ System.

Designed for easy delivery of therapy across complex calcified lesions while reducing procedural costs, the system holds promise for advancing treatment options.

POWER-PAD-II Study, emphasized the potential for introducing an innovative treatment for calcified arterial disease, which could significantly improve patient outcomes.

The pivotal trial results will set the stage for a new treatment paradigm in IVL therapy, contributing to the dynamic landscape of medical advancements.






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