CHAPEL HILL, N.C., Aug. 27, 2024 /PRNewswire/ — SonoVascular, Inc., a private medical device company, has announced the successful initiation of its first human study with its SonoThrombectomyä System. The SonoVascular platform is an innovative ultrasound facilitated, thrombolytic enhanced thrombectomy system that utilizes multiple mechanisms of action to treat patients with venous thromboembolism (VTE). Specifically, the catheter-based system combines microbubble-mediated cavitation with lose dose thrombolytic delivery to more effectively treat clots in an atraumatic manner, with no blood loss.
This First-in-Human case was completed at the Hospital DIPRECA in Santiago, Chile under the supervision of Dr. Manuel Espíndola, vascular surgeon and Site Principal Investigator, with the assistance of Dr. Albrecht Krämer, vascular surgeon and Study Principal Investigator. The clinical team successfully used SonoVascular’s SonoThrombectomy System to treat deep vein thrombosis (DVT) involving the common and external iliac veins.
“We were extremely pleased to perform the first clinical case using the SonoThrombectomy System,” said Dr. Espíndola. “The RESONATOR catheter performed exceptionally well, successfully and very quickly removing the thrombus and, most importantly, without the typical blood loss commonly seen in mechanical thrombectomy procedures. The patient was discharged from the hospital within 48 hours and is now at home, asymptomatic, and recovering well.”
“The SonoThrombectomy System was effective at reducing thrombus burden while preserving vessel walls due to its unique and gentle approach,” added Dr. Krämer. “It is exciting that we achieved such a comprehensive result on the table with a very low dose of thrombolytic.”
“SonoVascular is pleased to initiate the First-in-Human trial of our SonoThrombectomy System,” said Daniel Estay, Founder and Chief Executive Officer of SonoVascular. “This milestone highlights our commitment to bring this transformational technology to market. The RESONATOR is a true next generation solution for the treatment of VTE that is designed to leverage the benefits of mechanical and pharmacological mechanisms while overcoming the drawbacks associated with catheter-based thrombectomy and thrombolysis devices.”
About Venous Thromboembolism
Venous thromboembolism is a condition that occurs when a blood clot forms in a vein. As many as 900,000 VTE events occur each year in the United States.¹ VTE includes deep vein thrombosis (DVT) and pulmonary embolism (PE). DVT occurs when a blood clot forms in a deep vein, usually in the lower leg, thigh or pelvis. The most serious complication of DVT happens when a part of the clot breaks off and travels through the bloodstream to the lungs, causing a PE. If the clot is large, it can stop blood from reaching the lungs and can be fatal. One-third to one-half of people who have a DVT will have long-term complications caused by damage to the valves in the vein called post-thrombotic syndrome (PTS).² In some cases, PTS symptoms can be so severe that a person becomes disabled. PE can be life-threatening, with 10-30% of individuals dying within one month of diagnosis.³
About SonoVascular, Inc.
SonoVascular designs and develops innovative therapeutic ultrasound-based medical devices for treating vascular disease. Founded in 2018, SonoVascular developed the SonoThrombectomy System, a novel pharmaco-mechanical ultrasound facilitated thrombectomy system for VTE that utilizes microbubble-mediated cavitation as a core enabling mechanism of action to more effectively remove VTE blood clots. The SonoThrombectomy System has been engineered to address and overcome the deficiencies and limitations of current interventional devices. It is a catheterization laboratory-based solution that has been designed to maximize the reduction in clot burden, reduce the dose and duration as well as enhance the delivery of thrombolytics to levels that optimize safety and effectiveness, and eliminate the need for patients to be treated in the ICU. SonoVascular is headquartered in Chapel Hill, NC.
For more information, visit www.sonovascular.com.
Contact:
SonoVascular, Inc.Daniel Estay
Founder and Chief Executive Officer
[email protected]
¹ Gregson J, Kaptoge S, Bolton T, et al. Cardiovascular Risk Factors Associated With Venous Thromboembolism. JAMA Cardiol. 2019;4(2):163–173. doi:10.1001/jamacardio.2018.4537.
² Wendelboe AM, Campbell J, McCumber M; Bratzler D; Ding K, Beckman M, Reyes N; Raskob G. The Design and Implementation of a New Surveillance System for Venous Thromboembolism using Combined Active and Passive Methods. American Heart Journal. 2015.
³ American Lung Association; https://www.lung.org/lung-health-diseases/lung-disease-lookup/pulmonary-embolism/learn-about-pulmonary-embolism#:~:text=Pulmonary%20embolism%20affects%20around%20900%2C000,that%20travel%20to%20the%20lungs
SOURCE SonoVascular, Inc.
