AngioDynamics Receives 510(k) Clearance for AlphaVac F1885 System in Treatment of PE

AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving patient quality of life, today announced that the United States Food and Drug Administration (FDA) has cleared the AlphaVac F18⁸⁵ System for the treatment of pulmonary embolism (PE), enhancing its utility in critical medical scenarios such as PE.

PE affects around 900,000 people in the United States every year and is the third leading cause of cardiovascular mortality in the nation.^1,2 Patients with sub-massive or intermediate-risk PE account for 35% to 55% of hospitalized patients with PE and have a mortality rate of 3% to 14%.^2,3

The expanded FDA indication allows for the utilization of the AlphaVac F18⁸⁵ System for the treatment of PE, which broadens the applicability of the AlphaVac F18⁸⁵ System in the non-surgical removal of thrombi or emboli from the venous vasculature. The indication expands treatment options for patients with PE, 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.”

In December 2023, AngioDynamics announced the completion of patient enrollment in its Acute Pulmonary Embolism Extraction Trial with the AlphaVac System (APEX-AV) study, a single-arm Investigational Device Exemption study that enrolled 122 patients with confirmed acute, intermediate-risk PE across 25 hospital-based sites in the United States to assess the AlphaVac F18⁸⁵ System for the treatment of PE.

The APEX-AV study was initiated in partnership with the widely respected Pulmonary Embolism Response Team (PERT) Consortium and led by co-Principal Investigators William Brent Keeling, MD, Associate Professor of Surgery, Department of Surgery, at the Emory University School of Medicine, and Immediate Past President, The PERT Consortium and Mona Ranade, MD, Assistant Professor, Interventional Radiology, at the David Geffen School of Medicine at UCLA.