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.

DALLAS, Texas, Aug. 29, 2026 /PRNewswire/ -- 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 al¹., 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 curve (AUC) activity. The trial design and rationale were published in Cardiovascular Revascularization Medicine (DOI: 10.1016/j.carrev.2026.03.002).²

About enVast™

The Vesalio enVast™ is the first and only CE-marked and FDA-cleared clot retriever engineered for coronary thrombectomy. Built with Vesalio's proprietary Drop Zone™ Technology, enVast is designed to conform to the vessel wall, enabling distal-to-proximal clot engagement with circumferential clot capture and controlled clot retrieval under concomitant aspiration. enVast is indicated for the non-surgical removal of thrombus burden from coronary blood vessels.

About Vesalio

Vesalio is a privately held medical device company focused on advancing the treatment of thromboembolic vascular disease through innovative technologies designed to improve patient care and clinical outcomes. Vesalio's proprietary NeVa®, enVast™, and pVasc® platforms are designed to remove a broad range of clot types and restore blood flow to compromised ischemic tissue in the brain, heart, and peripheral vasculature.

Vesalio products have been used to treat more than 20,000 patients in more than 60 countries. For more information, visit www.vesalio.com.

Investor Contacts
Steve Rybka, CEO, Vesalio
[email protected] 

J.D. McCulloch, CFO, Vesalio
[email protected]

References

¹Spirito A, Quagliana A, Coiro M, et al. A prospective, first-in-human use of the NeVa mechanical thrombectomy device for patients with acute coronary syndromes. EuroIntervention. 2022;18:242-252. doi: 10.4244/EIJD-21-00741

²Landi A, Biscaglia S, Cuculi F,et al. The use of mechanical thrombectomy in patients with STEMI and large thrombus burden: design and rationale of the NATURE trial. Cardiovascular Revascularization Medicine DOI: 10.1016/j.carrev.2026.03.002

#enVast #coronarythrombectomy #STEMI #NATURE

enVast is FDA-cleared and CE-marked. See vesalio.com/envast-ifu-fda or vesalio.com/envast-ifu-ce depending on your region, for indications, safety and warnings.

SOURCE Vesalio