Sirtex Medical Launches Lava Liquid Embolic System

October 27, 2023—Sirtex Medical announced the commercial availability of the Lava liquid embolic system (LES), which is approved for the treatment of peripheral vascular hemorrhage.

According to the company, Lava provides volume and viscosity options to treat patients with controlled target vessel occlusion. Lava’s 2-mL and 6-mL options are optimized for the peripheral vasculature. Its viscosity options allow for the distal embolization of small vessels that may be inaccessible via other embolics.

“This product’s ability to maximize the packing density within the target vessel is incredibly important, as it allows us to minimize the likelihood of a future recurrence or restoration of vessel patency,” commented Gary Siskin, MD, in the Sirtex press release. Dr. Siskin is Professor and Chairman of the Department of Radiology at Albany Medical Center in Albany, New York.

Sirtex noted that in a study of the Lava LES for the embolic treatment of arterial hemorrhage in peripheral vasculature, the product met both the primary safety and effectiveness endpoints, with 100% of patients experiencing no major adverse events in 30 days and 94% of lesions meeting clinical success in 30 days.

Bulent Arslan, MD, stated in the press release, “The trial was an incredible success. Our goal was to achieve 70% efficacy for the existing data and outcomes, but we were able to achieve 94% efficacy. I’m overjoyed that it’s now available for all of our patients.” Dr. Arslan is Professor of the Division of Interventional Radiology and Director of Vascular and Interventional Radiology at Rush Medical College in Chicago, Illinois

FDA approval of the Lava LES, which was announced in April 2023, was based on its clinical evaluation in the prospective, multicenter, single-arm LAVA Study of safety and efficacy in acute peripheral arterial hemorrhages. The LAVA study was commenced in 2021 by Sirtex Medical and BlackSwan Vascular, Inc. under a strategic collaboration of the companies that was announced in December 2020.