Innova Vascular's Laguna® Thrombectomy System Surpasses Primary Endpoints in Pivotal TRUST Study for Pulmonary Embolism

IRVINE, CA, UNITED STATES, October 5, 2026 /EINPresswire.com/ -- Innova Vascular, Inc., a medical technology company developing minimally invasive treatments for blood clots in the vascular system, today announced positive results from its pivotal TRUST (Treating Pulmonary Embolism with Laguna Thrombectomy System) study evaluating the Laguna^® Thrombectomy System for the treatment of pulmonary embolism (PE).

The Laguna^® Thrombectomy System, comprised of the Malibu^® Aspiration Catheter System and the Laguna Clot Retriever^® System, was previously cleared by the U.S. Food and Drug Administration (FDA) for use in the peripheral vasculature. The TRUST study was conducted to evaluate the platform for a potential expansion of its indication to include the treatment of pulmonary embolism. Results were presented by Global Co-Principal Investigator S. Jay Mathews, MD, at the Vascular InterVentional Advances (VIVA) conference in Las Vegas.

TRUST Study Design

TRUST was a prospective, single-arm, multicenter pivotal study designed to evaluate the safety and effectiveness of the Laguna^® Thrombectomy System in patients with acute pulmonary embolism. The study enrolled 107 patients across 17 centers, including 13 centers in the United States, with participation from 30 operators.

All enrolled patients completed the 48-hour follow-up assessment, with additional follow-up conducted through 30 days.

Primary Results

The TRUST study achieved its primary effectiveness endpoint, demonstrating a mean absolute reduction of 0.53 in the right ventricular-to-left ventricular (RV/LV) ratio at 48 hours. This result significantly exceeded the prespecified performance goal of 0.12 (p < 0.0001).

The study also achieved its primary safety endpoint. The composite major adverse event rate within 48 hours was 0.9% (1/107), significantly below the prespecified performance goal of 25% (p < 0.001). The single event was a GUSTO moderate major bleeding event adjudicated by an independent clinical events committee as unrelated to the study device.

There were:
• No deaths
• No treatment-related cardiorespiratory deterioration
• No pulmonary vascular injuries
• No cardiac injuries

Secondary and Procedural Outcomes

Additional study findings included:
• A 35.2% reduction in CT-assessed clot burden, as measured by the Refined Modified Miller Score
• Improvement in patient-reported breathlessness, with mean Borg scores decreasing from 4.9 to 2.0 at 48 hours
• Immediate reductions in pulmonary artery pressures following treatment, including a 7.2 mmHg decrease in mean pulmonary artery pressure and an 11.6 mmHg decrease in systolic pulmonary artery pressure

All 107 procedures were completed successfully using the study device.

Procedural outcomes included:
• Mean thrombectomy procedure time of 37.6 minutes
• Mean post-procedure intensive care unit (ICU) stay of 0.48 days
• No use of thrombolytic therapy during the procedure or within 48 hours of treatment
• Sponsor representatives absent in 92% of procedures, reflecting the intuitive design and ease of use of the system

At 30-day follow-up, no deaths, symptomatic recurrent pulmonary embolism, or device-related serious adverse events were reported.

Physician Perspectives

"The results of the TRUST study confirm the safety, efficacy, and efficiency of the Laguna Thrombectomy System for the management of intermediate-risk pulmonary embolism. When cleared by the FDA for this indication, this will represent an exciting new option in the pulmonary embolism intervention space," said S. Jay Mathews, MD, MS, FACC, FSCAI, Director of the Cardiac Catheterization Laboratory, Pulmonary Embolism Response Team (PERT), and Structural Heart Program at Manatee Memorial Hospital and Global Co-Principal Investigator of the TRUST study.

"The Laguna Thrombectomy System offers an easy-to-use and intuitive clot removal platform that includes both large- and intermediate-bore aspiration options. Its incorporation of a mechanical mechanism to engage and remove organized, large, or wall-adherent thrombus that might otherwise be challenging to extract is a meaningful differentiator," said Kenneth Rosenfield, MD, Section Head for Vascular Medicine and Intervention at Massachusetts General Hospital.

"TRUST represents an important step forward in understanding how contemporary mechanical thrombectomy can impact patients with pulmonary embolism. What is most meaningful is seeing a therapy translate into rapid clinical improvement for patients who need it most. I'm proud to have been part of this global effort and grateful to the investigators, study teams, and patients who made it possible," said Raj Khalsa, MD, Division Chief of Interventional Radiology at Harbor-UCLA Medical Center and Global Co-Principal Investigator of the TRUST study.

Leadership Perspective

"The TRUST study reflects our commitment to generating robust 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 whose participation and dedication made the successful completion of this study possible. Additionally, we look forward to completing enrollment in the TRUST sub-study evaluating our Crescent Blood Return System," said Sanjay Shrivastava, Ph.D., Founder and Chief Executive Officer of Innova Vascular, Inc.

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 the Laguna Clot Retriever^® System, providing physicians with complementary technologies for thrombus removal. Innova Vascular is committed to advancing minimally invasive therapies for vascular thromboembolism through innovation, physician collaboration, and clinical research.

Indications for Use

The Laguna^® Thrombectomy System and Malibu^® Aspiration Catheter System are indicated in the United States for:
• The non-surgical removal of emboli and thrombi from peripheral blood vessels.
• The injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

The Laguna^® Thrombectomy System is intended for use in the peripheral vasculature.

Note: The Laguna^® Thrombectomy System is currently indicated for use in the peripheral vasculature. Pulmonary embolism data presented from the TRUST study are intended to support a potential future expansion of the device's indication for use.

Media and Investor Contact:

Sanjay Shrivastava, Ph.D., CEO
Innova Vascular
+1 949-295-6040
ss@innovavascular.com
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