TRUST Pivotal Study of Innova Laguna Thrombectomy System Completes Enrollment

September 1, 2026—Innova Vascular, Inc. announced the completion of patient enrollment in the TRUST pivotal investigational device exemption clinical study, which is evaluating the safety and effectiveness of the company’s Laguna thrombectomy system for the treatment of pulmonary embolism (PE). The TRUST study enrolled 107 patients across 17 clinical sites.

According to Innova, the Laguna system combines aspiration and mechanical clot retrieval technologies. The Malibu aspiration catheter system is designed with a range of intermediate- and large-bore aspiration catheter options, including 12-, 16-, 20-, and 24-F outer diameters. The Laguna clot retriever system is designed to mechanically delaminate, engage, and retrieve thrombus and may be used in conjunction with the Malibu aspiration catheter system, at the physician’s discretion.

“The ability to choose between intermediate-bore (12- or 16-F) and large-bore (20- or 24-F) aspiration catheters gives physicians the flexibility to tailor their approach to the individual patient based on vessel anatomy, clot burden, morphology, and location,” commented TRUST investigator Mahmood Razavi, MD, in the company’s press release.

The Global Coprincipal Investigators of the TRUST study, S. Jay Mathews, MD, and Raj Khalsa, MD, also discussed the device and the trial in the Innova Vascular press release.

“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,” stated Dr. Mathews. “Completion of enrollment in the TRUST study represents an important milestone toward potentially bringing this unique and highly navigable technology to physicians treating patients with PE.”

Dr. Khalsa added, “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. Completion of enrollment represents an important milestone for Innova Vascular and the TRUST clinical program. 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 on October 5, 2026.”