Vesalio has reported that the NATURE randomised controlled trial of its enVast Coronary Clot Retriever met the primary endpoint.
The device demonstrated a significant reduction in infarct size for patients with ST-segment elevation myocardial infarction (STEMI) and large thrombus burden (LTB) undergoing primary percutaneous coronary intervention (PCI).
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The findings were presented by Cardiocentro Ticino Institute principal investigator and cardiology chief professor Marco Valgimigli during the Late-Breaking Clinical Trials session at the 2026 ESC Congress in Germany.
NATURE is a prospective, multi-centre study. It enrolled 154 patients at 11 centres, where participants were randomised equally to receive either enVast-assisted mechanical thrombectomy followed by conventional PCI or standard care.
The primary endpoint, reduction in infarct size as measured by creatine kinase-MB (CK-MB) area-under-the-curve, showed a nearly 26% decline in the enVast group compared to standard care, reflecting a statistically significant decrease in myocardial damage.
Cardiac magnetic resonance imaging (CMR), assessed as a secondary endpoint, demonstrated a 25% relative reduction in infarct size as a percentage of left ventricular mass at day 3 in the enVast arm.
Safety outcomes over 30 days also favoured enVast. There were no strokes or deaths reported in the enVast group, compared with rates of 1.3% and 2.6% respectively in the control group.
Major adverse cardiovascular events (MACE) occurred in 1.3% of the enVast arm and 3.8% of the control group.
Vesalio CEO Steve Rybka said: “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.”
The NATURE results follow previous first-in-human research by Spirito et al., which examined enVast’s impact on myocardial reperfusion and found a favourable safety profile.
enVast is CE-marked and FDA-cleared, designed for mechanical removal of thrombus burden from coronary arteries.
In December 2025, the FDA granted 510(k) clearance for Vesalio’s enVast clot retriever, paving the way for its commercial launch in the US.
