The TRUST study enrolled 107 patients across 17 clinical sites and evaluated the Laguna Thrombectomy System, an endovascular platform that combines aspiration and mechanical clot-retrieval technologies. The system is comprised of the Malibu® Aspiration Catheter System and the Laguna Clot Retriever® System.
The Malibu Aspiration Catheter System offers physicians a range of intermediate- and large-bore aspiration catheter options, including 12Fr, 16Fr, 20Fr, and 24Fr outer diameters. The Laguna Clot Retriever System is designed to mechanically delaminate, engage, and retrieve thrombus and may be used, at the physician’s discretion, in conjunction with the Malibu Aspiration Catheter System.
“Being able to deliver catheters deep into the pulmonary vasculature with ease, speed, and safety is an important aspect of performing thrombectomy in patients with pulmonary embolism,” said Dr. S. Jay Mathews, MD, MS, Director of the Cardiac Catheterization Lab, PERT, and Structural Heart at Manatee Memorial Hospital and Global Co-Principal Investigator of the TRUST study. “Completion of enrollment in the TRUST study represents an important milestone toward potentially bringing this unique and highly navigable technology to physicians treating patients with PE.”
“The ability to choose between intermediate-bore (12Fr or 16Fr) and large-bore (20Fr or 24Fr) aspiration catheters gives physicians the flexibility to tailor their approach to the individual patient based on vessel anatomy, clot burden, morphology, and location,” said Dr. Mahmood Razavi, MD, Director of Clinical Trials at Providence Saint Joseph’s Medical Center and an investigator in the TRUST study.
“We are grateful to the patients who participated in the study and to the investigators and research teams whose dedication and commitment made the TRUST study possible,” said Dr. Raj Khalsa, MD, Division Chief of Interventional Radiology at Harbor-UCLA Medical Center and Global Co-Principal Investigator of the TRUST study. “Completion of enrollment represents an important milestone for Innova Vascular and the TRUST clinical program. We look forward to completing our analysis of the study and sharing the findings with the medical community at the VIVA Conference in Las Vegas on October 5, 2026.”
About Pulmonary Embolism
Pulmonary embolism occurs when a blood clot, typically originating in the deep veins of the body, travels to the lungs and obstructs blood flow through the pulmonary arteries. Depending on the severity of the embolism, PE can place significant stress on the cardiovascular system and may require rapid intervention.
Mechanical thrombectomy is a minimally invasive endovascular treatment approach designed to remove thrombus from the pulmonary vasculature without the need for open surgery. The use of mechanical thrombectomy has continued to evolve as physicians seek treatment options for patients with clinically significant pulmonary embolism.
“Understanding the properties of blood clots and their interactions with both medical devices and the vessel wall is fundamental to developing safe and effective thrombectomy technologies,” said Dr. Sanjay Shrivastava, Ph.D., CEO and Founder of Innova Vascular, Inc. “At Innova Vascular, we work closely with physicians and apply scientific and engineering rigor to develop innovative solutions to challenging clinical problems. The TRUST study reflects our commitment to generating clinical evidence for technologies designed to address important unmet needs in the treatment of pulmonary embolism. We are grateful to the patients, investigators, and clinical research teams who contributed to this important milestone.”
About Innova Vascular, Inc.
Innova Vascular, Inc. is a medical technology company focused on developing innovative endovascular solutions for the treatment of vascular disease. The company’s Laguna® Thrombectomy System combines the Malibu® Aspiration Catheter System and Laguna Clot Retriever® System to provide physicians with complementary technologies for thrombus removal.
Innova Vascular is committed to advancing minimally invasive therapies for vascular thromboembolism through innovative technology, physician collaboration, and clinical research.
For more information, contact:
Sanjay Shrivastava, Ph.D., CEO
Innova Vascular
+1 949-295-6040
ss@innovavascular.com
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