NATURE Randomized Controlled Trial Meets Primary Endpoint Evaluating enVast-Assisted Mechanical Thrombectomy in Large-Thrombus STEMI

Results showed a reduction in infarct size compared with conventional PCI in STEMI patients with large thrombus burden. Results were presented as Late-Breaking Science at ESC Congress 2026. Vesalio today announced results from the NATURE trial (NCT04969471), a prospective, randomized controlled, multi-center study evaluating the enVast™ Coronary Clot Retriever, a next generation stent-based thrombectomy technology, as an adjunctive reperfusion strategy to conventional intervention in patients with ST-segment elevation myocardial infarction (STEMI) and large thrombus burden (LTB) undergoing primary percutaneous coronary intervention (PCI). The results were presented by Prof. Marco Valgimigli, MD, Principal Investigator and Chief of Cardiology at the Cardiocentro Ticino Institute in Lugano, Switzerland during the Late-Breaking Clinical Trials session at the 2026 ESC Congress in Munich, Germany. "Large thrombus burden remains a significant challenge in primary PCI, and there is an ongoing need for effective strategies to improve myocardial reperfusion and limit infarct size," stated Prof. Marco Valgimigli, MD, PhD. "The reduction in infarct size demonstrated in NATURE, together with the favorable safety profile observed, represents important new evidence for mechanical thrombectomy in patients with LTB." Key findings Primary Efficacy endpoint: enVast reduced infarct size by nearly 26% compared with standard of care (p 0.001), as measured by CK-MB area-under-the-curve — a clinically meaningful reduction in myocardial damage. Infarct size on cardiac magnetic resonance imaging (CMR), a secondary endpoint, showed a positive trend favoring enVast, with a 25% relative reduction in infarct size (% of left ventricular mass) compared with standard of care at day 3. Safety: enVast demonstrated a favorable 30-day safety profile: No strokes in the enVast arm compared with 1.3% in the control group No deaths in the enVast arm compared with 2.6% in the control group Major adverse cardiovascular events (MACE) were lower in the enVast arm than in the control group, 1.3% vs. 3.8%, respectively The NATURE results build on the first-in-human study by Spirito et al 1 ., which evaluated the impact of enVast on myocardial reperfusion and reported a favorable safety profile. NATURE extends these findings by demonstrating the effect of enVast-enabled reperfusion at the myocardial tissue level, as measured by infarct size, while further affirming the favorable safety profile observed in the first-in-human experience. Together, these findings provide new evidence supporting the selective use of mechanical thrombectomy in STEMI patients with large thrombus burden. "We are grateful to the patients who participated in the NATURE trial and to the investigators and study teams whose dedication made this important study possible. The positive results from NATURE add meaningful evidence to the body of research in coronary thrombectomy," commented Steve Rybka, Chief Executive Officer of Vesalio. We are committed to advancing our understanding of the role of mechanical thrombectomy, and, ultimately, to improving treatment strategies and outcomes for STEMI patients with large thrombus burden." About the NATURE trial NATURE is a prospective, multicenter, two-arm, randomized controlled clinical trial assessing the safety and effectiveness of the enVast clot retrieval device as an adjunctive reperfusion strategy in STEMI patients with LTB undergoing primary PCI. 154 patients across 11 centers were randomized 1:1 to enVast-assisted mechanical thrombectomy followed by conventional PCI versus standard of care. The study was designed to evaluate whether mechanical removal of large thrombus burden could improve myocardial reperfusion and reduce myocardial injury in patients undergoing primary percutaneous coronary intervention (PCI). The primary endpoint was infarct size assessed by the creatine kinase-MB (CK-MB) area under the...