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August 13, 2026
Vesalio’s pVasc Net Mechanical Thrombectomy Device Receives FDA 510(k) Clearance
KEY TAKEAWAYS
- The FDA granted 510(k) clearance to Vesalio’s pVasc Net peripheral mechanical thrombectomy device.
- The device incorporates a fine-pore, dual-layer distal filter intended to capture clot fragments during retrieval.
- pVasc Net builds on Vesalio’s pVasc platform and supports radiopaque visualization and an aspiration-compatible workflow.
August 13, 2026—Vesalio announced that the FDA has granted 510(k) clearance for pVasc Net, the company’s next-generation peripheral mechanical thrombectomy device with an integrated distal filter.
Vesalio stated that the pVasc Net builds on the established pVasc platform, a self-expanding nitinol device delivered through a low-profile delivery catheter that is designed for the nonsurgical removal of emboli and thrombi from peripheral blood vessels.
The company further noted that the new pVasc Net design incorporates a fine-pore, dual-layer filter within the distal portion of the thrombectomy device. The integrated filter is designed to capture and retain clot fragments during clot retrieval while preserving the core features of Vesalio’s Drop Zone architecture.
The platform is designed to address a broad range of clot morphologies and provides radiopaque visualization as well as an aspiration-compatible workflow, stated Vesalio.
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