Innova Vascular says TRUST study met key pulmonary embolism endpoints

Innova Vascular said its Laguna Thrombectomy System met primary safety and effectiveness goals in the TRUST pivotal study for acute pulmonary embolism. The results, presented at the VIVA conference in Las Vegas, are intended to support a possible future FDA indication expansion beyond peripheral vasculature use.

Why it matters: - Positive pivotal data could help Innova Vascular expand the Laguna Thrombectomy System beyond its current U.S. indication in peripheral vasculature. - Pulmonary embolism treatment remains a high-stakes setting, where faster clot removal and lower bleeding risk can shape patient outcomes and hospital use.

What happened: - Innova Vascular announced positive results from TRUST, the pivotal study of the Laguna Thrombectomy System for acute pulmonary embolism. - The results were presented by Global Co-Principal Investigator S. Jay Mathews, MD, at the Vascular InterVentional Advances conference in Las Vegas. - TRUST enrolled 107 patients across 17 centers, including 13 centers in the U.S., with 30 operators participating. - All enrolled patients completed the 48-hour follow-up assessment, and follow-up continued through 30 days.

The details: - TRUST met its primary effectiveness endpoint with a mean absolute reduction of 0.53 in right ventricular-to-left ventricular ratio at 48 hours. - That result beat the prespecified performance goal of 0.12, with p < 0.0001. - TRUST also met its primary safety endpoint with a 0.9% composite major adverse event rate within 48 hours, or 1 of 107 patients. - The safety result was well below the prespecified performance goal of 25%, with p < 0.001. - The single event was a GUSTO moderate major bleeding event, and an independent clinical events committee judged it unrelated to the study device. - The study reported no deaths, no treatment-related cardiorespiratory deterioration, no pulmonary vascular injuries and no cardiac injuries. - Secondary findings included a 35.2% reduction in CT-assessed clot burden, measured by the Refined Modified Miller Score. - Mean Borg breathlessness scores fell from 4.9 to 2.0 at 48 hours. - Pulmonary artery pressures dropped immediately after 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. - Mean thrombectomy procedure time was 37.6 minutes. - Mean post-procedure ICU stay was 0.48 days. - No thrombolytic therapy was used during the procedure or within 48 hours after treatment. - Sponsor representatives were absent in 92% of procedures, which the company cited as evidence of intuitive use. - At 30 days, no deaths, symptomatic recurrent pulmonary embolism or device-related serious adverse events were reported. - The Laguna Thrombectomy System combines the Malibu Aspiration Catheter System and the Laguna Clot Retriever System. - The system is currently cleared by the FDA for use in the peripheral vasculature. - The company said the TRUST data are intended to support a potential future expansion of the device's indication for pulmonary embolism. - The Laguna Thrombectomy System and Malibu Aspiration Catheter System are indicated in the U.S. for non-surgical removal of emboli and thrombi from peripheral blood vessels and for injection, infusion and 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. - Innova Vascular also said it expects to complete enrollment in a TRUST sub-study of its Crescent Blood Return System.

Between the lines: - The combination of strong efficacy, low early adverse events and no 30-day device-related serious adverse events strengthens the case for a broader commercial and regulatory push. - A single-arm pivotal design means the study compares results against preset performance goals, not a randomized control group. - The low rate of sponsor presence suggests the platform may be operationally simpler for physicians and clinical teams.

What's next: - Innova Vascular is likely to use TRUST as part of a future FDA submission for a pulmonary embolism indication. - The company said it is continuing work on the TRUST sub-study evaluating the Crescent Blood Return System. - The company's announcement is available on LinkedIn.