Sirtex Medical and BlackSwan Vascular, Inc. announce first patient enrolled in pivotal LAVA Study
LAVA clinical trial underway for potential first FDA-approved liquid embolic system for a peripheral vascular indication
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 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," said Dr. Clayton Commander, Assistant Professor of Radiology at University of North Carolina School of Medicine, who treated the first patient in the LAVA Study. "The system has been well studied in pre-clinical 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 (PV) field."
LAVA is led by co-principal investigators Dr. Bulent Arslan at the Rush University Medical Center in Chicago and Dr. Mahmood Razavi at St. Joseph Heart and Vascular Center in Orange, California. The study population will include subjects with active arterial bleeding from the peripheral vasculature.
"We are thrilled for the launch of the LAVA Study, which has the potential to lead to the first FDA-approved liquid embolic for a PV application in the U.S.," said Kevin Smith, Chief Executive Officer of Sirtex. "We are proud to partner with BlackSwan on its clinical journey and look forward to the potential expansion of treatment options in the endovascular field for interventionalists and patients in need."