Vesalio has reported positive results from the NATURE randomised controlled trial evaluating its enVast Coronary Clot Retriever in patients with ST-segment elevation myocardial infarction and a large thrombus burden.
The prospective, randomised, multicentre study met its primary endpoint, with enVast-assisted mechanical thrombectomy reducing infarct size compared with conventional percutaneous coronary intervention.
The results were presented as late-breaking clinical trial data at the European Society of Cardiology Congress 2026 in Munich.
NATURE evaluated enVast as an adjunctive reperfusion strategy before conventional PCI in patients presenting with STEMI and a large thrombus burden.
Large coronary thrombi can complicate primary PCI by increasing the risk of distal embolisation and impaired microvascular reperfusion even after the main coronary artery has been reopened.
The enVast Coronary Clot Retriever uses a stent-based mechanical thrombectomy approach to retrieve clot from the coronary circulation before conventional intervention.
Professor Marco Valgimigli, Principal Investigator of the NATURE trial and Chief of Cardiology at Cardiocentro Ticino Institute in Lugano, Switzerland, presented the findings during the Late-Breaking Clinical Trials session at ESC Congress 2026.
The findings provide randomised evidence supporting the use of mechanical thrombectomy in a selected subgroup of STEMI patients with substantial thrombus burden.
The study is particularly relevant because routine manual aspiration thrombectomy has not become standard treatment for all STEMI patients, creating interest in more targeted device-based approaches for patients with high thrombus burden.
Vesalio received US Food and Drug Administration 510(k) clearance for enVast in December 2025.
The device is also CE marked.
The NATURE results add to the clinical evidence supporting Vesalio’s coronary thrombectomy platform and could help define the role of next-generation mechanical clot retrieval alongside primary PCI in complex STEMI cases.
