Innova Vascular's Laguna® Thrombectomy System Surpasses Primary Endpoints in TRUST Study

Innova Vascular's Laguna® Thrombectomy System has demonstrated significant effectiveness and safety in treating acute pulmonary embolism, according to results from the TRUST study. The system, which consists of the Malibu® Aspiration Catheter System and the Laguna Clot Retriever® System, was evaluated in a prospective, single-arm, multicenter pivotal study involving 107 patients across 17 centers, including 13 in the United States, with participation from 30 operators.

The TRUST study aimed to assess the safety and effectiveness of the Laguna® Thrombectomy System in managing intermediate-risk pulmonary embolism. The primary effectiveness endpoint was met, with a mean absolute reduction of 0.53 in the right ventricular-to-left ventricular (RV/LV) ratio at 48 hours, significantly exceeding the prespecified performance goal of 0.12 (p < 0.0001). Additionally, the primary safety endpoint was achieved, with a composite major adverse event rate of 0.9% (1/107) within 48 hours, well below the prespecified performance goal of 25% (p < 0.001). The single event was a GUSTO moderate major bleeding event, adjudicated as unrelated to the study device.

Secondary and procedural outcomes were also positive. The system reduced CT-assessed clot burden by 35.2%, as measured by the Refined Modified Miller Score. Patient-reported breathlessness improved, with Borg scores decreasing from 4.9 to 2.0 at 48 hours. Pulmonary artery pressures also saw immediate reductions, with 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, with a mean thrombectomy procedure time of 37.6 minutes and a mean post-procedure intensive care unit (ICU) stay of 0.48 days. Notably, no use of thrombolytic therapy was required during the procedure or within 48 hours of treatment, and sponsor representatives were absent in 92% of procedures, highlighting 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. The study's results confirm the safety, efficacy, and efficiency of the Laguna Thrombectomy System for the management of intermediate-risk pulmonary embolism, as stated by 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.

Innova Vascular's commitment to generating robust clinical evidence for technologies addressing unmet needs in pulmonary embolism treatment is evident in the successful completion of the TRUST study. The company looks forward to completing enrollment in the TRUST sub-study evaluating its Crescent Blood Return System.