The US Food and Drug Administration (FDA) has cleared Vesalio’s pVasc NET, expanding the company’s existing pVasc technology portfolio for the treatment of thromboembolic disease in the peripheral vasculature.
The Texas-based company’s newly cleared device incorporates a fine-pore, dual-layer filter within the distal portion of the device, designed to capture and retain clot fragments following retrieval while preserving the core features of its proprietary ‘drop zone’ architecture.
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Vesalio’s drop zone architecture refers to the proprietary clot-capture design incorporated into existing devices within its mechanical thrombectomy portfolio. Instead of relying on a standard mesh that pins a blood clot against the artery wall, the drop zone design uses large, recessed pockets – referred to as drop zones – along the device that trap and cradle thrombi inside the structure.
Peripheral thrombectomy can be particularly challenging in small or diseased vessels where maintaining control and preserving available runoff are important considerations, noted Gustavo Prado, Vesalio’s vice president of development and regulatory, highlighting that pVasc NET builds on the “proven design principles” of its drop zone platform while adding an integrated clot capture filter.
Vesalio’s CEO, Steve Rybka, said: “This FDA clearance represents an important expansion of our peripheral vascular portfolio and brings a differentiated technology to physicians treating thromboembolic disease across challenging anatomy.
“We believe pVasc NET will provide physicians with an important new tool for peripheral thrombectomy.”
Vesalio also has a product line designed for neurovascular use, along with specialist stent-based retriever devices.
Boston Scientific’s Penumbra acquisition the biggest thrombectomy deal in 2026 to date
GlobalData analysis reveals that the global thrombectomy market is growing at a CAGR of 5.5% and poised to almost double its valuation in 2035 to over $6bn, up from around $3.5bn in 2025.
The space saw a pronounced shakeup in Q1 with Boston Scientific’s $14.5bn acquisition of computer-assisted vacuum thrombectomy (CAVT) specialist Penumbra. Announced during the J.P. Morgan Healthcare conference in January, at the time, GlobalData’s senior analyst Ashley Clarke said that by using its global infrastructure, Boston can “potentially help scale and integrate Penumbra’s mechanical thrombectomy and vascular technologies into hospitals and health systems faster than Penumbra could alone.”
