Dallas, Texas, August 13, 2026
Vesalio announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for pVasc NET, a next-generation peripheral mechanical thrombectomy device featuring an integrated distal filter. The regulatory milestone expands Vesalio’s pVasc® platform and introduces an integrated clot-capture technology designed to retain clot fragments during retrieval. The device is being developed for the non-surgical removal of emboli and thrombi from peripheral blood vessels, addressing challenges associated with treating thromboembolic disease in complex peripheral vasculature.
pVasc NET Adds Integrated Clot-Capture Technology
pVasc NET builds on Vesalio’s established pVasc platform, which uses a self-expanding nitinol device delivered through a low-profile delivery catheter. The platform is designed to mechanically remove emboli and thrombi from peripheral blood vessels without requiring open surgical intervention. The new pVasc NET configuration incorporates a fine-pore, dual-layer filter within the distal portion of the thrombectomy device. This integrated filter is designed to capture and retain clot fragments as the device retrieves thrombotic material from the vessel. The integrated filter represents a key design feature intended to provide physicians with greater control during mechanical thrombectomy procedures. By retaining clot fragments during retrieval, the technology is designed to address an important consideration in peripheral thrombectomy, particularly when treating small or diseased vessels. Vesalio said the device maintains core elements of its proprietary Drop Zone™ architecture, while adding the distal filtering capability to the platform. pVasc NET also incorporates radiopaque visualization and an aspiration-compatible workflow, allowing the device to support procedural visualization and integration with established thrombectomy techniques. According to the company, the platform is designed to address a broad range of clot morphologies and challenging peripheral anatomy.
FDA Clearance Expands Peripheral Thrombectomy Options
The FDA 510(k) clearance represents an important regulatory milestone for Vesalio’s peripheral vascular portfolio. The company said pVasc NET maintains the low-profile delivery system and straightforward procedural workflow associated with its pVasc platform while introducing integrated clot-capture technology. The combination is intended to provide physicians with an additional tool for treating peripheral thromboembolic disease. Peripheral thrombectomy can present technical challenges because physicians may need to remove thrombotic material while maintaining vessel control and preserving available blood flow through downstream vessels. Vesalio’s integrated distal filter is designed around these considerations by capturing clot fragments during retrieval. The company believes this approach can support thrombectomy procedures in anatomically challenging vessels while retaining the established delivery characteristics of its platform. The clearance also broadens Vesalio’s portfolio of technologies designed to treat thromboembolic vascular disease. The company develops vascular intervention systems intended to remove different types of clot and restore blood flow to ischemic tissue in multiple vascular territories.
Advertisement
Vesalio Expands Vascular Intervention Technology
Vesalio’s broader technology portfolio includes the NeVa®, enVast™, and pVasc® platforms, which are designed for applications involving the brain, heart, and peripheral vasculature. The company reports that its products have been used to treat more than 20,000 patients in more than 60 countries, reflecting its growing presence in vascular intervention. The pVasc NET clearance adds another technology to this portfolio and reinforces Vesalio’s focus on mechanical thrombectomy and clot-removal technologies. By incorporating a fine-pore distal filter directly into the thrombectomy device, the company aims to provide physicians with a system that combines clot retrieval and fragment capture within a single platform.
The latest regulatory authorization highlights continued innovation in MedTech and endovascular intervention, where device manufacturers are developing increasingly specialized tools for the treatment of thromboembolic conditions. While FDA clearance establishes the regulatory pathway for the device, ongoing clinical use and physician experience will help determine its practical role across different peripheral thrombectomy procedures. For Vesalio, the pVasc NET FDA clearance marks a significant step in expanding access to its peripheral vascular technology. The company expects the device to provide physicians treating challenging peripheral anatomy with another option for mechanical clot removal, while its integrated distal filter is designed to retain clot fragments throughout the retrieval process.
Source: Vesalio press release
