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. 

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. 

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.”