Dallas, Texas, August 29, 2026
Vesalio announced positive results from the NATURE randomized controlled trial, evaluating the company’s enVast™ Coronary Clot Retriever as an adjunctive mechanical thrombectomy device in patients with ST-segment elevation myocardial infarction (STEMI) and a large thrombus burden (LTB). The findings showed that enVast-assisted thrombectomy reduced myocardial infarct size compared with conventional percutaneous coronary intervention (PCI) and were presented as Late-Breaking Science at the 2026 European Society of Cardiology (ESC) Congress in Munich, Germany. The results add clinical evidence for selective mechanical clot removal in a high-risk STEMI population undergoing primary PCI.
NATURE Trial Demonstrates Reduced Infarct Size
The prospective, multicenter NATURE Phase clinical trial randomized 154 patients across 11 centers in a 1:1 ratio to receive enVast-assisted mechanical thrombectomy followed by conventional PCI or standard-of-care PCI. The study was designed to determine whether mechanical removal of a substantial coronary thrombus burden could improve myocardial reperfusion and reduce myocardial injury in patients experiencing STEMI. The trial met its primary efficacy endpoint, with enVast-assisted treatment producing a nearly 26% reduction in infarct size compared with conventional treatment. Infarct size was assessed using the creatine kinase-MB (CK-MB) area under the curve (AUC), a measure used to quantify myocardial injury following an acute coronary event. The reported difference was statistically significant, with a p-value of 0.001, supporting the study’s predefined primary endpoint. Cardiac magnetic resonance (CMR) imaging, included as a secondary measure of infarct size, also showed a favorable trend. At Day 3, infarct size expressed as a percentage of left ventricular mass was approximately 25% lower with enVast compared with standard care. Together, the findings suggest that mechanical thrombectomy may have an effect beyond restoration of epicardial blood flow by potentially reducing myocardial tissue injury in selected STEMI patients with substantial thrombus.
Favorable 30-Day Safety Outcomes Reported
The NATURE trial also evaluated the 30-day safety profile of enVast-assisted treatment. According to the reported results, there were no strokes in the enVast treatment arm, compared with 1.3% in the control group. Similarly, no deaths were reported in the enVast arm, compared with 2.6% among patients receiving standard care. Major adverse cardiovascular events (MACE) were also numerically lower in the enVast group, occurring in 1.3% of patients compared with 3.8% in the control group. These findings contribute to the safety assessment of the device and support continued investigation of mechanical thrombectomy as an adjunct to primary PCI in patients with large thrombus burden. The company said the NATURE findings build on earlier first-in-human experience with mechanical thrombectomy technology, extending evaluation from reperfusion measures to myocardial tissue-level outcomes and infarct size. However, the reported results should be interpreted within the context of the trial’s sample size and study design.
Advertisement
enVast Advances Coronary Thrombectomy Technology
The enVast™ Coronary Clot Retriever is a stent-based thrombectomy device designed for the non-surgical removal of thrombus from coronary blood vessels. According to Vesalio, the device uses proprietary Drop Zone™ Technology to conform to the vessel wall and facilitate distal-to-proximal clot engagement, circumferential clot capture and controlled retrieval under aspiration. Vesalio states that enVast is the first and only CE-marked and FDA-cleared clot retriever specifically engineered for coronary thrombectomy. The company is focused on technologies for treating thromboembolic vascular disease across coronary, cerebral and peripheral vascular applications. The NATURE results provide additional clinical evidence supporting the potential role of mechanical thrombectomy in STEMI patients with large thrombus burden, a population in which effective clot management remains an important procedural challenge. The findings may help inform future research into patient selection and thrombectomy strategies alongside conventional PCI. Continued clinical evaluation will be important to determine how the technology could be incorporated into treatment pathways and whether the observed reduction in infarct size translates into improved long-term cardiovascular outcomes.
Source: Vesalio press relese
