US-based device company AngioDynamics shows its AlphaVac F1885 system is safe for patients with acute intermediate-risk pulmonary embolism (PE), resulting in significant improvements in right ventricular function and reduced clot burden. announced new data.
Data from the APEX-AV trial showed a 0.45 decrease in RV/LV ratio after 48 hours, exceeding the expected improvement of 0.12. Serious adverse events occurred in only 4.1% of cases, much lower than the expected incidence of 25%. Furthermore, the amount of blood clots decreased by an average of 35.5% after the procedure.
This data was presented at the Society for Cardiovascular Angiography and Interventions (SCAI) 2024 Scientific Sessions on May 3, 2024 in Long Beach, California.
Angiodynamics ended patient enrollment for the APEX-AV study in December 2023. This single-arm investigational device exemption study enrolled 122 patients with confirmed acute intermediate-risk PE at 25 hospital sites in the United States. The company initiated his APEX-AV study in collaboration with the Pulmonary Embolism Response Team (PERT) consortium.
The AlphaVac MMA F1885 system is an emergency first-line device and is currently approved to remove thromboembolism from the venous system. Features an ergonomic handle, obturator, his 18F cannula with an 85° angle, and a waste bag assembly. The system received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the treatment of PE following the announcement that the APEX-AV trial met its primary and secondary endpoints.
PE, known as deep vein thrombosis (DVT), is a serious condition in which blood clots form in blood vessels in the lungs, usually from deep veins in the legs. This blockage can be life-threatening, causing cardiac arrest or stroke. The venous thromboembolism market, which includes DVT and PE, is expected to generate global sales of $11.8 billion by 2032, according to a report by GlobalData's Pharma Intelligence Center.
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In August 2023, AngioDynamics received breakthrough device designation from the FDA for its AngioVac system for non-surgical removal of right heart vegetation.
In a presentation accompanying the data, co-principal investigator William Keeling said: “The safety and efficacy results observed in the APEX-AV trial, as well as the remarkable reduction in clot burden, highlight the importance of incorporating this technology into the treatment of patients with acute PE.” ”