Vesalio today announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for pVasc NET, a peripheral mechanical thrombectomy device featuring an integrated distal filter.
According to the company, pVasc NET builds on the established pVasc platform, a self-expanding nitinol device delivered through a low-profile delivery catheter and designed for the non-surgical removal of emboli and thrombi from peripheral blood vessels.
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 proprietary Drop Zone architecture. The platform is designed to address a broad range of clot morphologies and provides radiopaque visualisation as well as an aspiration-compatible workflow.
“Peripheral thrombectomy can be particularly challenging in small or diseased vessels, where maintaining control and preserving available runoff are important considerations,” said Gustavo Prado, vice president of Development and Regulatory at Vesalio. “pVasc NET builds on the proven design principles of our Drop Zone platform by incorporating an integrated filter designed to retain clot fragments during retrieval, while maintaining the low-profile delivery system and straightforward workflow physicians value.”
“This US FDA clearance represents an important expansion of our peripheral vascular portfolio and brings a differentiated technology to physicians treating thromboembolic disease across challenging anatomy,” said Steve Rybka, chief executive officer of Vesalio. “We believe pVasc NET will provide physicians with an important new tool for peripheral thrombectomy.”
