The expanded FDA indication allows for the use of AlphaVac F18 system for the treatment of PE. The new indication expands the device’s use in the non-surgical removal of thrombi or emboli from the venous vasculature.
“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,” Juan Carlos Serna, senior VP of scientific and clinical affairs, said in a news release. “In addition to meeting our primary endpoints, the trial also showed a meaningful, favorable reduction in clot burden, ultimately improving patient outcomes.”
Pulmonary embolisms affect around 900,000 people in the U.S. annually and are the third leading cause of cardiovascular mortality, according to AngioDynamics. Patients who have sub-massive or intermediate-risk of PE account for 35% to 55% of hospitalized patients with PE and typically have a mortality rate of 3% to 14%.
AlphaVac data shows promise in treating PE
AngioDynamics completed patient enrollment in its Acute Pulmonary Embolism Extraction Trial with the AlphaVac System (APEX-AV) study in December 2023. The study was a single-arm investigational device exemption study that enrolled 122 patients with confirmed acute, intermediate-risk PE in 25 hospital-based sites in the U.S. to assess the AlphaVac F18 system in treating PE.
“The addition of the AlphaVac System in the mechanical thrombectomy world is a critical step forward in the treatment of PE patients,” said Dr. William Brent Keeling, a co-principal investigator on the study and an associate professor of surgery at Emory University School of Medicine. “The rapid patient enrollment and the excellent safety and efficacy outcomes from the APEX-AV study validate the need for such technologies to be part of the PE treatment algorithm.”
According to AngioDynamics, the primary efficacy endpoint in the study was the reduction of the RV/LV ratio between baseline and 48 hours post-procedure. The primary safety endpoint was the rate of major adverse events (MAEs) within the first 48 hours. Patients were also followed for 30 days post-index procedure.
Study results showed there was a mean decrease in the RV/LV ratio for baseline to 48 hours post-procedure of 0.45 and a MAEs rate of 4.1%. There was also a 35.5% mean reduction in clot burden from baseline to 48 hours post-procedure.
“Catheter-based therapies are becoming a major tool in the PE space,” said Dr. John Moriarty, president-elect of the Pulmonary Embolism Response Team (PERT) Consortium and an interventional radiology professor at UCLA. “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.”
