AngioDynamics has announced that the United States Food and Drug Administration (FDA) has cleared their AlphaVac F1885 system for the treatment of pulmonary embolism (PE).
According to the press release, the AlphaVac F1885 System is a non-surgical alternative for the removal of thrombi or emboli from the venous vasculature. AngioDynamics says that this expands treatment options for PE patients, reducing thrombus burden and improving right ventricular function.
“FDA clearance marks a significant advancement in patient care and safety. This milestone underscores our commitment to merging physician-centric design with patient outcome-driven solutions,” said Juan Carlos Serna, AngioDynamics Senior Vice President of Scientific and Clinical Affairs. “In addition to meeting our primary endpoints, the trial also showed a meaningful, favorable reduction in clot burden, ultimately improving patient outcomes.”
AngioDynamics began the Acute Pulmonary Embolism Extraction Trial with the AlphaVac System (APEX-AV) in December of 2023. The single-arm Investigational Device Exemption study enrolled 122 patients with acute intermediate-risk PTE to assess the AlphaVac F1885 System.
Mona Ranade, MD, assistant professor of interventional radiology at the David Geffen School of Medicine at the University of California, Los Angeles, said “The 510(k) clearance of the AlphaVac System represents an important milestone towards the treatment of PE. The data from the APEX-AV study showed a significant improvement in the RV function and a rapid resolution of clot burden in the pulmonary arteries.”
John M. Moriarty, MD, president-elect of the PERT Consortium and professor of interventional radiology at the University of California, Los Angeles, said “Catheter-based therapies are becoming a major tool in the PE space. With a handle that can limit blood loss and a true large bore cannula with a 33 Fr funnel, I expect the AlphaVac System to play a crucial role in the treatment of PE.”
