AVS Receives IDE Approval from FDA for Pivotal Intravascular Lithotripsy Study

BOSTON--(BUSINESS WIRE)--Amplitude Vascular Systems (AVS), a medical device company focused on safely and effectively 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 begin its pivotal trial for pulsatile intravascular lithotripsy (PIVL) therapy. The POWER-PAD-II clinical study will evaluate the safety and efficacy of AVS’s Pulse IVL™ System for the treatment of patients with severely calcified peripheral arterial disease in the United States.

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