Vesalio Secures FDA Clearance for enVast Clot Retriever

Coronary thrombectomy system gains US FDA clearance

Vesalio has announced US Food and Drug Administration (FDA) 510(k) clearance and the upcoming US commercial launch of enVast, a clot retriever specifically cleared for mechanical thrombectomy in the cardiac circulation. Large thrombus burden (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 minimising myocardial damag…

Vesalio secures FDA clearance for enVast clot retriever

The Food and Drug Administration (FDA) has granted 510(k) clearance for Vesalio’s enVast clot retriever, paving the way for its commercial launch in the US.The post Vesalio secures FDA clearance for enVast clot retriever appeared first on Medical Device Network.

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 c…