SonoVascular SonoThrombectomy System FIH Study Presented With Initial Results

March 27, 2025—SonoVascular, Inc. recently announced it has successfully completed an initial set of eight cases in patients with deep vein thrombosis (DVT) in its first-in-human (FIH) study of the SonoThrombectomy system for venous thromboembolism treatment.

The company stated that the SonoThrombectomy system is designed to deliver ultrasound energy and microbubbles directly to the clot through the Resonator catheter, inducing microbubble-mediated cavitation that mechanically breaks down the clot. Additionally, a very low dose of tissue plasminogen activator is infused in combination with the microbubbles through the catheter to further improve clot breakdown. SonoVascular announced the initiation of the FIH study in August 2024.

According to SonoVascular, treatment with the SonoThrombectomy system was effective in the first eight cases of the FIH study—all cases achieved a 100% Marder score reduction as assessed by an independent core laboratory. Additionally, significant improvements from baseline in Villalta score, revised Venous Clinical Severity Score, and Numeric Pain Rating Scale scores were observed at 30-day follow-up, and there were no device-related adverse events, major bleeding, or deaths.

The initial clinical results were presented by William Marston, MD, at the 2025 annual meeting of the American Venous Forum held February 16-19 in Atlanta, Georgia. Dr. Marston, who is Past President of the American Venous Forum, is Professor of Surgery at the University of North Carolina at Chapel Hill School of Medicine in Chapel Hill, North Carolina.

“The results obtained thus far in SonoVascular’s FIH study demonstrate the SonoThrombectomy system has the potential to become a disruptive technology that would effectively overcome the shortcomings of available therapies for the treatment of DVT,” commented Dr. Marston in the company’s press release. “As a vascular surgeon and researcher who has treated patients suffering from DVT for over 25 years, I find that despite improvements in our ability to treat these patients, currently available devices still have significant challenges and limitations.”

He continued, “In the initial cases, the SonoThrombectomy system has demonstrated its ability to eliminate intravenous clot in a single treatment session with no blood loss and with preservation of venous valves. The system is not limited by the presence of previously implanted filters or stents and is highly steerable for treatment of specific areas of residual thrombus.”

Dr. Marston concluded in the press release, “These initial cases suggest that the SonoThrombectomy system is able to eliminate clot with a gentler approach that does not cause blood loss and preserves vessel and valve integrity. This system has the potential to be a revolutionary technology and address critical limitations with current interventional devices and techniques for treatment of DVT.”