Innova Vascular has announced the completion of patient enrolment in the TRUST pivotal investigational device exemption (IDE) clinical study evaluating the safety and effectiveness of the Laguna thrombectomy system for the treatment of pulmonary embolism (PE).
The TRUST study enrolled 107 patients across 17 clinical sites and evaluated the Laguna system—an endovascular platform that combines aspiration and mechanical clot-retrieval technologies. The system is comprised of the Malibu aspiration catheter system and the Laguna clot retriever system.
In a recent press release, the company details that the Malibu system offers physicians a range of intermediate- and large-bore aspiration catheter options, including 12Fr, 16Fr, 20Fr, and 24Fr outer diameters. The Laguna clot retriever system is designed to mechanically delaminate, engage, and retrieve thrombus and may be used, at the physician’s discretion, in conjunction with the Malibu system.
“Being able to deliver catheters deep into the pulmonary vasculature with ease, speed, and safety is an important aspect of performing thrombectomy in patients with PE,” said S Jay Mathews, director of the Cardiac Catheterisation Lab, pulmonary embolism response team (PERT), and Structural Heart at Manatee Memorial Hospital in Bradenton, USA and global co-principal investigator of the TRUST study. “Completion of enrolment in the TRUST study represents an important milestone toward potentially bringing this unique and highly navigable technology to physicians treating patients with PE.”
“The ability to choose between intermediate-bore (12Fr or 16Fr) and large-bore (20Fr or 24Fr) aspiration catheters gives physicians the flexibility to tailor their approach to the individual patient based on vessel anatomy, clot burden, morphology, and location,” said Mahmood Razavi, director of clinical trials at Providence Saint Joseph’s Medical Center in Burbank, USA and an investigator in the TRUST study.
“We are grateful to the patients who participated in the study and to the investigators and research teams whose dedication and commitment made the TRUST study possible,” said Raj Khalsa, division chief of Interventional Radiology at Harbor-UCLA Medical Center in West Carson, USA and global co-principal investigator of the TRUST study. “Completion of enrolment represents an important milestone for Innova Vascular and the TRUST clinical programme. We look forward to completing our analysis of the study and sharing the findings with the medical community at the VIVA conference in Las Vegas, USA on 5 October 2026.”
