Innova Vascular completes enrollment in TRUST pulmonary embolism study
Innova Vascular said it has finished enrolling patients in its TRUST IDE study of the Laguna Thrombectomy System for pulmonary embolism, a milestone in the company’s effort to generate clinical evidence for its endovascular clot-removal platform. The company plans to share study findings at the VIVA Conference in Las Vegas on Oct. 5, 2026.
Why it matters: - Pulmonary embolism can quickly strain the cardiovascular system and may require rapid intervention. - Innova Vascular’s TRUST study is testing whether the Laguna Thrombectomy System can safely and effectively remove clot from the pulmonary vasculature. - The study completion advances a pivotal clinical program that could support broader physician use of the system if results are favorable.
What happened: - Innova Vascular announced completion of patient enrollment in the TRUST pivotal Investigational Device Exemption clinical study. - The study evaluates the Laguna Thrombectomy System for treatment of pulmonary embolism. - TRUST enrolled 107 patients across 17 clinical sites. - The company said it expects to complete analysis of the study and present findings at the VIVA Conference in Las Vegas on Oct. 5, 2026.
The details: - The Laguna Thrombectomy System combines aspiration and mechanical clot-retrieval technologies. - The system includes the Malibu Aspiration Catheter System and the Laguna Clot Retriever System. - The Malibu system offers intermediate- and large-bore aspiration catheter options in 12Fr, 16Fr, 20Fr, and 24Fr outer diameters. - The Laguna Clot Retriever System is designed to mechanically delaminate, engage and retrieve thrombus. - The Laguna Clot Retriever System may be used with the Malibu Aspiration Catheter System at the physician’s discretion. - Dr. S. Jay Mathews, global co-principal investigator of the TRUST study, said deep catheter delivery into the pulmonary vasculature is important for performing thrombectomy in patients with pulmonary embolism. - Dr. Mahmood Razavi said the choice between intermediate-bore and large-bore aspiration catheters gives physicians flexibility to tailor treatment to vessel anatomy, clot burden, morphology and location. - Dr. Raj Khalsa said the study enrollment milestone reflects progress for Innova Vascular and the TRUST clinical program. - Innova Vascular describes the Laguna Thrombectomy System as a complementary technology set for thrombus removal.
Between the lines: - The enrollment milestone suggests the company is moving from trial recruitment toward data generation and potential regulatory and clinical-readout steps. - The repeated focus on catheter size, navigability and clot interaction signals that device design and procedural flexibility are central to the product story. - The VIVA Conference presentation could become the key near-term catalyst for investors and clinicians watching the program.
What's next: - Innova Vascular plans to finish its analysis of the TRUST study. - The company expects to share the findings with the medical community at VIVA in Las Vegas on Oct. 5, 2026. - Further progress will depend on the study results and how clinicians interpret the system’s safety and effectiveness profile.
The bottom line: - Innova Vascular has moved its Laguna thrombectomy platform one step closer to a potential clinical and commercial inflection point by completing enrollment in its pivotal pulmonary embolism study.
Disclaimer: This article was produced by AGP Wire with the assistance of artificial intelligence based on original source content and has been refined to improve clarity, structure, and readability. This content is provided on an “as is” basis. While care has been taken in its preparation, it may contain inaccuracies or omissions, and readers should consult the original source and independently verify key information where appropriate. This content is for informational purposes only and does not constitute legal, financial, investment, or other professional advice.
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