Vesalio Receives FDA 510(k) Clearance of enVast, the First Stent-Based Coronary Thrombectomy Technology

PLANO, Texas, Dec. 11, 2025 /PRNewswire/ -- Vesalio, a leader in thrombectomy solutions, today announced FDA 510(k) clearance and the upcoming U.S. commercial launch of enVast™, the first and only clot retriever specifically cleared for mechanical thrombectomy in the cardiac circulation. enVast introduces a proven, innovative approach to clot capture and removal, redefining coronary thrombectomy for patients with large thrombus burden (LTB).

LTB is a common and challenging finding in patients undergoing primary percutaneous coronary intervention (PCI). Prompt and effective restoration of coronary flow is critical to minimizing myocardial damage, reducing procedural complications, and improving clinical outcomes.

Powered by Vesalio’s proprietary Drop Zone® technology, enVast delivers comprehensive clot management by securely engaging and removing the full spectrum of coronary thrombi – from soft, fragment-prone clots to dense, fibrin-rich thrombi that are often resistant to existing aspiration or retrieval techniques. This advanced capability enables rapid and reliable thrombus extraction with restoration of flow to ischemic myocardium.

enVast is the first Vesalio product platform to receive regulatory clearance in both the United States as well as in Europe. Following strong clinical adoption in key international markets, this FDA clearance expands Vesalio’s U.S. portfolio to address another area of the anatomy burdened with vascular occlusions.

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