Right heart cardiac ultrasound contrast agent for shunts enters U.S. trial ASI-O2. Highlighted by MDPI. April 09, 2025<\/p>\n
1. ASI-02 is a novel right-heart ultrasound contrast agent developed by Agitated Solutions Inc. (ASI), now entering a Phase 3 clinical trial in the U.S. and Canada. MDPI.
\n2. The trial will include up to 300 patients undergoing transthoracic echocardiography (TTE) with agitated saline contrast to assess safety and efficacy.
\n3. ASI-02 aims to improve detection of right-to-left shunts (e.g., PFO or PAVM) by producing consistent, high-quality microbubbles, unlike current manual saline agitation methods.
\n4. The agent allows for single-operator use, simplifying workflow and eliminating the need for two personnel during bubble studies.
\n5. Current U.S. FDA-approved contrast agents (e.g., Definity, Optison, Lumason) are only used for left-heart imaging and are not suitable for shunt detection on the right side.
\n6. Agitated saline remains the standard for right-heart studies, but it suffers from inconsistency, lower image quality, and resource-intensive workflow.
\n7. ASI-02 offers the first innovation in this area in over 60 years and is already approved in Canada. It is still investigational in the U.S., pending FDA approval after the trial.
\n8. The goal of ASI-02 is to enable more accurate, efficient, and operator-friendly echocardiographic diagnosis of cardiac shunts.<\/p>\n