Vesalio’s enVast Coronary Thrombectomy Device Cleared by FDA

December 11, 2025—Vesalio announced FDA 510(k) clearance and the upcoming United States commercial launch of the enVast clot retriever. The enVast device is specifically cleared for mechanical thrombectomy in the cardiac circulation for large thrombus burden in patients undergoing primary percutaneous coronary intervention, noted the company.

According to Vesalio, enVast is powered by the company’s Drop Zone technology to deliver comprehensive clot management for 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—to restore flow to ischemic myocardium.

Vesalio noted that enVast is the company’s first product platform to receive regulatory clearance in both the United States and Europe; additionally, this FDA clearance expands its United States portfolio to address a new area of the anatomy with vascular occlusions.