BlackSwan Vascular, a privately held company that is developing innovative therapies in endovascular embolization, is has announced it has received US Food and Drug Administration (FDA) Premarket Approval (PMA) of its Lava Liquid Embolic System (Lava LES) for treatment of peripheral arterial haemorrhage.
Lava LES—a non-adhesive injectable—is the first liquid embolic product approved by the FDA for use in the peripheral vasculature and is specifically indicated for embolization of peripheral arterial haemorrhages. Liquid embolic agents, which are injected as a liquid and solidify after entering the vasculature, are used to treat a variety of conditions.
“Lava LES was purpose-built to provide interventional radiologists with an important tool to rapidly address challenging active arterial bleeds, including gastrointestinal bleeding and bleeding from trauma,” says BlackSwan CEO Suresh Pai. “Arterial bleeds frequently present in an emergent setting and can be life-threatening. We are delighted to bring this important technology to fruition to safely and effectively treat these patients.”
Premarket approval was granted based on clinical evaluation of Lava LES in a prospective, multicentre, single-arm study (the “LAVA study”) evaluating safety and efficacy in acute peripheral arterial haemorrhages. The study utilised composite outcomes as a measure of safety, documenting the percentage of cases that were free from major adverse events within a 30-day period following treatment. Effectiveness was determined by the percentage of cases that were clinically successful, with no bleeding from the target lesion after embolization with the Lava LES, and no need for emergency surgery, re-embolization, or other target lesion reinterventions within 30 days of the index procedure. Results of the study, which followed 113 patients at 20 centres demonstrated safety and efficacy outcomes that exceeded the pre-established performance goals of the study.
“Lava LES has been optimised for use in the peripheral circulation” based on viscosity, radiopacity, and volume, explains Mahmood K Razavi (Vascular & Interventional Specialists of Orange County, Orange, USA). As co-principal investigator of the LAVA study, Razavi presented the study findings at the 2023 Society of Interventional Radiologists Annual Meeting (SIR, 4–9 March, Phoenix, USA). “The study confirms that there are clear advantages to liquid embolics in peripheral applications,” he says. With this approval, “practitioners can be trained to use this highly effective form of embolization, to the benefit of patients.”
Lava LES was developed by BlackSwan, leveraging the infrastructure, resources and ISO 13485 and FDA QSR compliant quality systems of LamaMed, a med-tech venture studio with a successful track record of capital-efficient product development from concept to commercialisation.