Innova Vascular has announced positive results from the pivotal TRUST study, which evaluated the Laguna thrombectomy system for the treatment of pulmonary embolism (PE). The data were presented at the Vascular InterVentional Advances (VIVA) conference (4–7 October, Las Vegas, USA).
The Laguna thrombectomy system, which comprises the Malibu aspiration catheter system and the Laguna clot retriever System, was previously cleared by the US Food and Drug Administration (FDA) for use in the peripheral vasculature. TRUST was conducted to support a potential expansion of its indication to include PE, the company says in a press release.
TRUST was a prospective, single-arm, multicentre pivotal study of the system in patients with acute PE. It enrolled 107 patients across 17 centres, 13 of them in the USA, with 30 operators taking part. All patients completed the 48-hour follow-up assessment, and follow-up continued through 30 days.
The study met its primary effectiveness endpoint, with a mean absolute reduction in right ventricular-to-left ventricular (RV/LV) ratio of 0.53 at 48 hours. This significantly exceeded the prespecified performance goal of 0.12 (p<0.0001).
The primary safety endpoint was also met. The composite major adverse event rate within 48 hours was 0.9% (1/107), significantly below the prespecified performance goal of 25% (p<0.001). The single event was a Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) moderate major bleeding event, which an independent clinical events committee adjudicated as unrelated to the device. There were no deaths, treatment-related cardiorespiratory deterioration, pulmonary vascular injuries or cardiac injuries.
Secondary outcomes included a 35.2% reduction in computed tomography (CT)-assessed clot burden, measured by the Refined Modified Miller Score. Mean Borg breathlessness scores improved from 4.9 to 2.0 at 48 hours. Following treatment, mean pulmonary artery pressure fell by 7.2mmHg and systolic pulmonary artery pressure by 11.6mmHg.
All 107 procedures were completed successfully with the study device. Mean thrombectomy procedure time was 37.6 minutes and mean post-procedure intensive care unit (ICU) stay was 0.48 days. No thrombolytic therapy was used during the procedure or within 48 hours of treatment, and sponsor representatives were absent in 92% of cases. At 30 days, there were no deaths, symptomatic recurrent PE or device-related serious adverse events.
“The results of the TRUST study confirm the safety, efficacy and efficiency of the Laguna Thrombectomy System for the management of intermediate-risk PE. When cleared by the US FDA for this indication, this will represent an exciting new option in the PE intervention space,” said S Jay Mathews, director of the Cardiac Catheterisation Laboratory, Pulmonary Embolism Response Team (PERT) and Structural Heart Programme at Manatee Memorial Hospital, in Bradenton, USA, and global co-principal investigator of TRUST.
Kenneth Rosenfield, section head for vascular medicine and intervention at Massachusetts General Hospital in Boston, USA, added: “The Laguna thrombectomy system offers an easy-to-use and intuitive clot removal platform that includes both large- and intermediate-bore aspiration options. Its incorporation of a mechanical mechanism to engage and remove organised, large or wall-adherent thrombus that might otherwise be challenging to extract is a meaningful differentiator.”
Raj Khalsa, division chief of interventional radiology at Harbor-UCLA Medical Center, USA, and fellow global co-principal investigator, said: “What is most meaningful is seeing a therapy translate into rapid clinical improvement for patients who need it most. I’m proud to have been part of this global effort and grateful to the investigators, study teams and patients who made it possible.”
