BlackSwan Vascular’s Lava Liquid Embolic System Approved for Peripheral Arterial Hemorrhage

April 19, 2023—BlackSwan Vascular, Inc., a California-based company developing therapies in endovascular embolization, announced it has received FDA premarket approval for the Lava liquid embolic system (LES). The nonadhesive injectable Lava LES is indicated for embolization of peripheral arterial hemorrhages.

According to the company, FDA approval was granted based on the clinical evaluation of Lava LES in the LAVA Study, a prospective, multicenter, single-arm evaluation of safety and efficacy in acute peripheral arterial hemorrhages.

The LAVA study, which was composed of 113 patients enrolled at 20 centers, demonstrated safety and efficacy outcomes that exceeded the pre-established performance goals.

Safety was measured by the rate of freedom from major adverse events at 30 days. Effectiveness was determined by the percentage of cases that were clinically successful, with no bleeding from the target lesion after embolization with the Lava LES, and no need for emergency surgery, re-embolization, or other target lesion reinterventions at 30 days from the index procedure.

Mahmood K. Razavi, MD, who served as coprincipal investigator of the LAVA study, presented the study findings at the Society for Interventional Radiology’s annual scientific meeting held March 4-9, 2023, in Phoenix, Arizona. Dr. Razavi is Director of Clinical Trials and Research Center at Vascular & Interventional Specialists of Orange County in Orange, California.