The study is designed to assess the safety and efficacy of the BlackSwan Lava liquid embolic system
Liver cancer therapies provider Sirtex Medical and liquid embolic products provider BlackSwan Vascular have recruited the first patient in the LAVA Study.
The LAVA Study, which stands for liquid embolisation of arterial hemorrhages in peripheral vasculature, is designed to assess the safety and efficacy of the BlackSwan Lava liquid embolic system (LES) for the embolic treatment of arterial hemorrhage in the peripheral vasculature.
Sirtex and BlackSwan will enroll 113 subjects in the prospective and multicentre single-arm study at 20 investigational sites in the US.
The companies have recruited the subject at the University of North Carolina School of Medicine in North Carolina. Lava LES has been successfully used by the clinical team to treat a patient with a bleeding hypervascular tumor in the liver.
The LAVA Study will evaluate the primary safety endpoint of a composite of freedom from 30-day major adverse events and the primary effectiveness endpoint of clinical success.
It is defined as absence of bleeding from the target lesion after embolisation with the Lava LES, without the requirement for emergency surgery, re-embolisation or other target lesion reinterventions within 30 days of the index procedure.
Sirtex CEO Kevin Smith said: “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 US.
“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.”
The LAVA Study enrollment comes after the establishment of the collaboration between Sirtex and BlackSwan in December last year.
As part of the collaboration, Sirtex made a significant equity investment in exchange for preferred shares in BlackSwan.
Sirtex is also provided with an option to acquire the remaining shares of the company at an agreed price.