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Vesalio's enVast Trial Shows Significant Heart Attack Damage Reduction
31 Aug
Summary
- Device significantly reduced infarct size in STEMI patients with large thrombus burden.
- Nearly 26% reduction in infarct size measured by CK-MB area-under-the-curve.
- No strokes or deaths occurred in the enVast group over 30 days.
Vesalio's enVast Coronary Clot Retriever has achieved its primary endpoint in the NATURE randomized controlled trial. The study focused on patients with ST-segment elevation myocardial infarction (STEMI) and large thrombus burden undergoing percutaneous coronary intervention.
The prospective, multi-center study enrolled 154 patients, randomly assigning them to either enVast-assisted thrombectomy or standard care. Results presented at the 2026 ESC Congress in Germany showed a nearly 26% decrease in infarct size, as measured by creatine kinase-MB, for the enVast group compared to the control.
Secondary endpoints using cardiac magnetic resonance imaging also indicated a 25% relative reduction in infarct size. Safety outcomes over 30 days favored enVast, with zero strokes or deaths in its arm versus 1.3% and 2.6% respectively in the control group.
The enVast device, which is CE-marked and FDA-cleared, is designed for mechanical thrombus removal from coronary arteries. Its FDA 510(k) clearance was granted in December 2025, allowing for its commercial launch in the US.
