Innova’s Laguna Thrombectomy System Evaluated in TRUST Pivotal Study for PE Indication

October 6, 2026—Innova Vascular, Inc. announced results from its pivotal TRUST study evaluating the treatment of pulmonary embolism (PE) with the company’s Laguna thrombectomy system.

According to the company, the TRUST study was conducted to evaluate the Laguna platform for a potential expansion of its indication for use to include the treatment of PE. On August 31, the company announced completion of patient enrollment in the study.

The Laguna thrombectomy system, which comprises the Malibu aspiration catheter system and the Laguna clot retriever system, has been cleared by the FDA for use in the peripheral vasculature. The Laguna and Malibu systems are currently indicated for the nonsurgical removal of emboli and thrombi from peripheral blood vessels and for the injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

S. Jay Mathews, MD, Global Coprincipal Investigator of TRUST, presented the results at VIVA 2026, the Vascular Interventional Advances conference.

“The results of the TRUST study confirm the safety, efficacy, and efficiency of the Laguna thrombectomy system for the management of intermediate-risk PE,” commented Dr. Mathews in the Innova Vascular press release. “When cleared by the FDA for this indication, this will represent an exciting new option in the PE intervention space.”

Innova Vascular stated that TRUST is a prospective, single-arm, multicenter pivotal study designed to evaluate the safety and effectiveness of the Laguna thrombectomy system in patients with acute PE.

The study enrolled 107 patients across 17 centers, including 13 centers in the United States, with participation from 30 operators. All 107 procedures were completed successfully using the study device.

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

As summarized in Innova’s press release, the TRUST study achieved its primary effectiveness endpoint, demonstrating a mean absolute reduction of 0.53 in the right ventricular/left ventricular ratio at 48 hours. This result significantly exceeded the prespecified performance goal of 0.12 (P < .0001), noted the company.

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 < .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, and no cardiac injuries, noted the company.

Innova also stated that the secondary outcomes included the following:

• A 35.2% reduction in CT-assessed clot burden, as measured by the refined modified Miller score.
• An 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 (PAPs) after treatment, including a 7.2 mm Hg decrease in mean PAP and an 11.6 mm Hg decrease in systolic PAP.

Procedural outcomes included a mean thrombectomy procedure time of 37.6 minutes and mean postprocedure intensive care unit stay of 0.48 days. There was no use of thrombolytic therapy during the procedure or within 48 hours of treatment. Additionally, sponsor representatives were absent in 92% of procedures, reflecting the intuitive design and ease of use of the system, noted the press release.

At 30-day follow-up, no deaths, symptomatic recurrent PE, or device-related serious adverse events were reported, advised Innova Vascular.