EkoSonic™ Endovascular System

Ultrasonic Technology

Control Unit

Clinical Evidence

Reimbursement

Overview

Pulmonary Embolism Evidence

HI-PEITHO Trial

Clinical Trials

With Level 1, Long-Term, and Quality of Life data, EKOS is the most studied device in the space.

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STUDY NAME	STUDY DESCRIPTION (LEVEL)	STATUS
	Venous Thromboembolism: Deep Venous Thrombosis*
CAVA	A randomised controlled multicenter trial comparing ultrasound-accelerated catheter-directed thrombolysis, combined with standard anticoagulant therapy, with standard anticoagulant therapy alone, for acute primary iliofemoral deep vein thrombosis (Level 1)	Enrolling
ACCESS PTS	Accelerated Thrombolysis for Post-Thrombotic Syndrome Using the EKOS System (Level 2) Chronicdvtstudy.com	Completed

	Venous Thromboembolism: Pulmonary Embolism
ULTIMA	Ultrasound Accelerated ThrombolysIs of Pulmonary Embolism (Level 1)	Completed
SEATTLE II	A Prospective, Single-Arm, Multi-center Trial of EKOS for Acute Pulmonary Embolism (Level 2)	Completed
OPTALYSE PE	Study of the Optimum Duration of Acoustic Pulse Thrombolysis Procedure in the Treatment of Acute Submassive Pulmonary Embolism (Level 2)	Completed

	Arterial Occlusion*
DUET	Dutch randomized trial comparing standard catheter-directed thrombolysis versus ultrasound-accelerated thrombolysis for thrombo-emoblic infra-inguinal	Completed
DUET II	Dutch randomized trial comparing standard catheter-directed thrombolysis versus ultrasound-accelerated thrombolysis for thrombo-emoblic infra-inguinal	Start-up

*Safety and effectiveness have not been established in this patient population

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