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Vesalio

PharmaDeviceNews Vesalio
Vesalio’s FDA-cleared pVasc NET thrombectomy device combines clot retrieval with integrated distal filtration, putting a new approach to peripheral clot removal on track for a controlled US commercial launch later in 2026. Representative image.
Medical Devices & Diagnostics

FDA clears Vesalio pVasc NET for peripheral mechanical thrombectomy

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Vesalio for pVasc NET, a peripheral mechanical thrombectomy device that combines a self-expanding clot retriever with a fine-pore, dual-layer filter positioned at its distal end. The FDA classified the device as substantially equivalent through the Special 510(k) pathway on August 5, 2026. Vesalio

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Medical Devices & Diagnostics

Can Vesalio’s enVast reshape coronary thrombectomy with stent-based retrieval?

Vesalio has received 510(k) clearance from the U.S. Food and Drug Administration for enVast, its stent-based coronary clot retrieval system, making it the first device of its kind approved for mechanical thrombectomy in the cardiac circulation. The approval authorizes enVast for U.S. commercialization, following prior regulatory clearance and use in European markets. The device is

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