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

The FDA clearance of enVast redefines coronary thrombectomy treatment and further expands Vesalio's commercial platform.

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.

"With FDA clearance and upcoming U.S. launch of enVast, we are proud to introduce a device that we truly believe redefines coronary thrombectomy," said Steve Rybka, CEO of Vesalio. "enVast is the first coronary-specific retriever designed with a stent-based clot capture architecture enhanced by our proprietary Drop Zone technology. Clinical experience internationally has consistently demonstrated its safety and effectiveness in managing complex LTB situations. We're excited to now make this impactful solution available to U.S. interventional cardiologists and their patients."

About Vesalio
Founded in 2017, Vesalio is a privately held medical device company focused on advancing patient care in thromboembolic vascular disease by providing physicians with superior technology for improving clinical outcomes. Vesalio's proprietary NeVa®, enVast™, and pVasc® platforms are designed to effectively remove all types of clots and restore vital blood flow to compromised ischemic tissue in the brain, heart, and peripheral anatomy. Vesalio's products have treated more than 15,000 patients in over 60 countries. For more information, visit www.vesalio.com.

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

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

SOURCE Vesalio