#United States #Chapel Hill #SonoVascular #SonoThrombectomy #Venous Thromboembolism

Pioneering Developments in Vascular Treatment: SonoThrombectomy™ Makes Waves

At the recent 2025 Annual Meeting of the American Venous Forum, the innovative medical device company, SonoVascular, Inc., presented groundbreaking first-in-human clinical results for its newly developed device, the SonoThrombectomy™ System. This system is tailored for the treatment of venous thromboembolism (VTE), specifically targeting conditions like deep vein thrombosis (DVT) and pulmonary embolism (PE). These conditions are serious health risks resulting from clots that form in the veins, significantly affecting blood flow and potentially leading to life-threatening complications.

The SonoThrombectomy System employs an advanced technique involving ultrasound energy and microbubbles that are directly delivered to the blood clot through a specialized RESONATOR™ Catheter. The technology harnesses a unique microbubble-mediated cavitation process, which facilitates the mechanical breakdown of clots. This novel treatment also employs a low-dose tissue plasminogen activator (tPA), enhancing clot dissolution in tandem with the ultrasound treatment.

Clinical Efficacy and Results

In an initial study involving eight patients suffering from DVT, the results were promising. Remarkably, all cases documented a complete reduction in Marder scores, indicating total resolution of the thrombus, assessed by an independent core laboratory. Following up after 30 days, significant improvements were observed in various scoring metrics, such as the Villalta score and the Numeric Pain Rating Scale. Notably, there were no adverse events related to the device, major bleeds, or fatalities reported among the participants.

Daniel Estay, the founder and CEO of SonoVascular, expressed optimism about the preliminary outcomes, highlighting, “The results so far are encouraging. Our study has showcased complete clot resolution and no instances of blood loss or other safety concerns.” Enrollment for this pivotal study is ongoing, with expectations to complete by the end of Q2 2025.

Dr. William Marston, a prominent figure in vascular surgery and one of the presenters at the conference, underscored the revolutionary potential of the SonoThrombectomy System. He indicates that the technology might address existing limitations in current thrombolytic therapies, which often pose challenges in efficiency or safety. According to him, “These initial cases suggest that the SonoThrombectomy System can eliminate clot with a gentler, more effective approach, preserving vessel integrity.”

Understanding Venous Thromboembolism

VTE is a critical medical issue affecting approximately 900,000 individuals annually in the United States alone. The formation of clots in deep veins poses serious risks, and if a portion of these clots migrates to the lungs, pulmonary embolism can occur, leading to a substantial number of fatalities. Approximately 10-30% of PE patients may pass away within a month after diagnosis, further illustrating the urgency for novel treatment options. Moreover, long-term complications such as post-thrombotic syndrome affect a significant portion of DVT patients, which can lead to debilitating conditions due to damage to venous valves.

Long-term solutions and improved state-of-the-art technologies are vital to advancing care within this area. The SonoThrombectomy System's ability to effectively address these challenges with minimal blood loss and without adversely affecting surrounding venous structures sets a new precedent in the realm of vascular treatment.

Conclusion

SonoVascular's innovative approach offers a renewed hope for optimal patient outcomes in the treatment of DVT and PE, which hold the potential for revolutionizing care in vascular medicine. As clinical trials progress, global healthcare communities remain attentive to the implications of these findings for wider clinical practices. Healthcare professionals and policymakers alike will watch the advancements persistently, as they can significantly alter therapeutic landscapes for millions affected by VTE.

For further updates on SonoVascular and its initiatives, visit www.sonovascular.com.