FDA OKs Vesalio’s Stent-Based Coronary Thrombectomy Tech

Vesalio, a developer of thrombectomy solutions, has gained U.S. Food and Drug Administration (FDA) 510(k) clearance and announced upcoming U.S. launch of its enVast clot retriever.

The company touts enVast as the first and only clot retriever specifically cleared for mechanical thrombectomy in the cardiac circulation. Vesalio hopes the technology will redefine coronary thrombectomy for patients with large thrombus burden (LTB).

The clot retriever is powered by the company’s Drop Zone technology and securely engages and removes the full spectrum of coronary thrombi, the company said. It can remove soft, fragment-prone clots to dense, fibrin-rich thrombi that are often resistant to existing aspiration or retrieval techniques. The capability allows rapid, reliable thrombus extraction with restoration of flow to ischemic myocardium.

enVast is the first Vesalio product platform to earn regulatory nods in both the U.S. and Europe. This FDA clearance expands the company’s U.S. portfolio to treat 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.”