US medtech AngioDynamics has initiated a trial of its AlphaVac F1885 thrombectomy system for treating patients with acute pulmonary embolism (PE).
The company’s AlphaVac system, which received CE marking in Europe and 510(k) clearance from the US Food and Drug Administration (FDA) earlier this year, uses a funnel cannula design for the non-surgical and manual aspiration of blood clots in PE patients.
Following the initiation of a similar trial in the US last year, the RECOVER-AV study will enrol patients with confirmed acute, intermediate-risk PE in up to 20 European hospitals.
The study’s primary endpoint is a reduction in the right ventricular/left ventricular (RV/LV) ratio from baseline to 48 hours post-procedure. The study also includes a primary safety endpoint for assessing the incidence of major adverse events (MAEs), such as device-related death or major bleeding, within seven days.
Previous research has estimated that around 435,000 PE events occur in the six largest European nations annually while other research indicates that compared to the US, PE incidence is higher for patients admitted to emergency departments in Europe, and with higher acuity and worse patient outcomes overall.
AngioDynamics senior vice-president and general manager of endovascular therapies Laura Piccinini commented: “With our clinical partners, we are demonstrating our continued commitment to generating robust clinical evidence across the world, with this being the first international study we have sponsored highlighting our commitment as a global leader to treat more patients and advance care.”
According to GlobalData, the global manual thrombectomy device market was valued at around $157m in 2023 and is forecast to reach a valuation of around $174m by 2033.
Elsewhere in thrombectomy, FlowPhysix (formerly Expanse ICE) recently partnered with 3comma Medical for the international distribution of its aspiration catheter, the FlowRunner Aspiration System.
