BlackSwan Vascular PMA for Arterial Hemorrhage OK’d

FDA has approved a BlackSwan Vascular PMA for its Lava Liquid Embolic System for treating peripheral arterial hemorrhage. The company describes the device as a “liquid embolic product” specifically indicated for embolization of peripheral arterial hemorrhages. Liquid embolic agents are injected as a liquid and solidify after entering the vasculature, it says.

Approval was based on clinical data from a prospective, multicenter, single-arm study (the LAVA study) evaluating safety and efficacy in acute peripheral arterial hemorrhages, the company says. “The study utilized composite outcomes as a measure of safety, documenting the percentage of cases that were free from major adverse events within a 30-day period following treatment,” it says. “Results of the study, which followed 113 patients at 20 centers demonstrated safety and efficacy outcomes that exceeded the pre-established performance goals of the study.”