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BlackSwan Vascular Wins FDA Premarket Approval of Innovative New Treatment for Peripheral Arterial Hemorrhages

Sirtex Medical and BlackSwan Vascular, Inc announce first patient enrolled in pivotal LAVA Study

Share this article Share this article WOBURN, Mass., April 19, 2021 /PRNewswire/  Sirtex Medical (Sirtex), a leading manufacturer of targeted liver cancer therapies, and BlackSwan Vascular, Inc. (BlackSwan), a Bay Area-based private company developing groundbreaking therapies in endovascular embolization, announced that the first patient has been enrolled in the LAVA Study to evaluate the safety and effectiveness of the BlackSwan Lava™ liquid embolic system (LES) for the embolic treatment of arterial hemorrhage in the peripheral vasculature. The LAVA Study, which stands for Liquid Embolization of Arterial Hemorrhages in Peripheral Vasculature, is a prospective, multicenter single-arm study of 113 subjects at 20 investigational sites in the U.S. The first subject has been enrolled at the University of North Carolina School of Medicine in Chapel Hill, North Carolina, where a clinical team successfully treated a patient with a bleeding hypervascular tumor in the liver using

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