US-based device company AngioDynamics has announced new data that finds its AlphaVac F1885 System safe in patients with acute intermediate-risk pulmonary embolism (PE) and provides significant improvement in right ventricular function and reduction in clot burden.
Data from the APEX-AV trial demonstrated a decrease of 0.45 in the RV/LV ratio at 48 hours, surpassing the expected improvement of 0.12. Major adverse events occurred in only 4.1% of cases, much lower than the expected rate of 25%. Additionally, there was a 35.5% average reduction in clot burden after the procedure.
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The data was presented at the Society for Cardiovascular Angiography & Interventions (SCAI) 2024 scientific sessions hosted in Long Beach, California, on 3 May 2024.
AngioDynamics concluded patient enrolment in its APEX-AV trial in December 2023. The single-arm investigational device exemption study enrolled 122 patients with confirmed acute, intermediate-risk PE across 25 hospital-based sites in the US. The company started the APEX-AV Study in collaboration with the Pulmonary Embolism Response Team (PERT) Consortium.
The AlphaVac MMA F1885 System, an emergent first-line device, is currently approved to remove thromboembolisms from the venous system. It features an ergonomic handle, an obturator, an 18F cannula with an 85° angle and a waste bag assembly. The system received 510(k) clearance from the US Food and Drug Administration (FDA) last month to treat PE, following the announcement that the APEX-AV trial had met primary and secondary endpoints.
A PE is a serious medical condition where a blood clot forms in a blood vessel in the lungs, typically originating from the deep veins in the legs, known as deep vein thrombosis (DVT). This blockage can be life-threatening, causing a cardiac arrest or stroke. According to a report on GlobalData’s Pharma Intelligence Center, the venous thromboembolism market, which includes DVT and PE, will generate $11.8bn in global sales by 2032.
In August 2023, AngioDynamics received breakthrough device designation from the FDA for its AngioVac System for the non-surgical removal of right heart vegetation.
In the announcement accompanying the data, co-principal investigator William Keeling said: “The impressive reduction in clot burden, in addition to the safety and efficacy results observed in the APEX-AV trial, underscore the importance of integrating this technology into the treatment of acute PE.”
