Vesalio’s enVast for Mechanical Thrombectomy in Large-Thrombus STEMI Studied in NATURE

September 3, 2026—Vesalio announced results from the NATURE trial of the company’s enVast coronary clot retriever. The enVast device, a next-generation stent-based thrombectomy technology, has received CE Mark approval and FDA clearance, noted the company.

According Vesalio, the prospective, randomized controlled, multicenter NATURE study is evaluating enVast as an adjunctive reperfusion strategy to conventional intervention in patients with ST-segment elevation myocardial infarction and large thrombus burden (LTB) who are undergoing primary percutaneous coronary intervention (PCI).

In March 2026, the NATURE trial’s design and rationale were published by Antonio Landi, MD, et al in Cardiovascular Revascularization Medicine.

The study’s principal investigator, Professor Marco Valgimigli, MD, presented the results during the late-breaking clinical trials session at the European Society of Cardiology’s 2026 ESC congress. Additionally, the study findings have been accepted for publication and are available online in JACC, the Journal of the American College of Cardiology.

As outlined in the company’s press release, the key findings from NATURE include the following:

• In the primary efficacy endpoint, enVast reduced infarct size by approximately 26% compared with standard of care (P = .001), as measured by creatine kinase-myocardial band area-under-the-curve, representing a clinically meaningful reduction in myocardial damage.
• A secondary efficacy endpoint of infarct size on cardiac MRI 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.
• The 30-day safety findings for the enVast arm included no strokes versus 1.3% in the control arm; no deaths versus 2.6% in the control arm; and a 1.3% rate of major adverse cardiovascular events versus 3.8% in the control arm.

“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,” commented Prof. Valgimigli in Vesalio’s press release. “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.”

Vesalio advised that the NATURE results build on the first-in-human study published in 2022 by Alessandro Spirito, MD, et al in Eurointervention, which evaluated the impact of enVast on myocardial reperfusion and reported a favorable safety profile.