Sirtex Medical and BlackSwan Vascular Commence Pivotal LAVA Study

April 19, 2021—Sirtex Medical, a manufacturer of targeted liver cancer therapies, and BlackSwan Vascular, Inc., which is developing therapies in endovascular embolization, announced the commencement of the LAVA study evaluating 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 will assess the primary safety endpoint of a composite of freedom from 30-day major adverse events and the primary effectiveness endpoint of clinical success, defined as the absence of bleeding from the target lesion after embolization with the Lava LES, without the need for emergency surgery, re-embolization or other target lesion reinterventions within 30 days of the index procedure.

The prospective, multicenter single-arm LAVA study will enroll 113 patients at 20 investigational sites in the United States. The study is led by coprincipal investigators Bulent Arslan, MD, from the Rush University Medical Center in Chicago, and Mahmood Razavi, MD, from St. Joseph Heart and Vascular Center in Orange, California.

The first patient in the study has been enrolled at the University of North Carolina School of Medicine in Chapel Hill, North Carolina. Assistant Professor of Radiology Clayton Commander, MD, and a clinical team successfully treated the patient's bleeding hypervascular tumor in the liver using the Lava LES.

“I was able to experience first-hand the impact of embolization with the Lava LES for patient treatment, and I’m very pleased with the result,” commented Dr. Commander in the company’s press release. “The system has been well studied in preclinical testing, and we are thankful to BlackSwan for leading this clinical program with support from Sirtex that has the potential to bring meaningful advancement to the peripheral vascular field.”

The LAVA study enrollment follows the strategic collaboration of Sirtex and BlackSwan that was announced in December 2020. Under the collaboration, Sirtex made a significant equity investment in exchange for preferred shares in BlackSwan, as well as an option to purchase the remaining shares of the company at an agreed price.