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 haemorrhage in the peripheral vasculature, Sirtex Medical and BlackSwan Vascular have announced in a press release.
The LAVA study, which stands for Liquid embolization of arterial haemorrhages in peripheral vasculature, is a prospective, multicentre, single-arm study of 113 subjects at 20 investigational sites in the USA. The first patient has been enrolled at the University of North Carolina School of Medicine in Chapel Hill, USA, where a clinical team successfully treated a patient with a bleeding hypervascular tumour 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 am very pleased with the result,” says 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 programme with support from Sirtex that has the potential to bring meaningful advancement to the peripheral vascular field.”
LAVA is led by co-principal investigators Bulent Arslan at the Rush University Medical Center in Chicago, USA, and Mahmood Razavi at St Joseph Heart and Vascular Center in Orange, USA. The study population will include patients 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 US Food and Drug Administration [FDA]-approved liquid embolic for a peripheral vascular application in the USA,” comments 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.”
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 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.
“Currently, there is no liquid embolic agent that is indicated for peripheral vascular applications in the USA. Lava has key differentiators of optimised radiopacity, availability in two viscosities, reduced preparation time, and controlled delivery, which can enable treatment of a wide array of peripheral vascular diseases,” says Suresh Pai, Chief Executive Officer of BlackSwan. “Moving the LAVA study forward advances our mission to provide the interventional community with the tools they need that drive safe, effective, and value-based treatments. We are eager to discover the findings.”
The LAVA study enrollment follows the strategic collaboration Sirtex and BlackSwan entered 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.