The clearance broadens the applicability of the AlphaVac F1885 System in the non-surgical removal of thrombi or emboli from the venous vasculature.

RT’s Three Key Takeaways

  1. The AlphaVac F1885 System received FDA clearance for the treatment of pulmonary embolism, expanding indications for the system.
  2. The APEX-AV study, which enrolled 122 patients across 25 US sites, demonstrated the system’s effectiveness in reducing thrombus burden and improving right ventricular function.
  3. Results from the APEX-AV study showed a significant decrease in RV/LV ratio and a low rate of major adverse events, highlighting the system’s safety and efficacy in pulmonary embolism treatment.

AngioDynamics Inc announced that the US 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.

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.

APEX-AV Study Completion

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 Pulmonary Embolism Response Team (PERT) Consortium and led by co-principal investigators William Brent Keeling, MD, associate professor of surgery in the department of surgery at the Emory University School of Medicine and immediate past president of the PERT Consortium, and Mona Ranade, MD, assistant professor of interventional radiology at the David Geffen School of Medicine at UCLA.

Key Findings and Endorsements

“The addition of the AlphaVac System in the mechanical thrombectomy world is a critical step forward in the treatment of PE patients,” says Keeling in a release. “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.”

The primary efficacy endpoint of the APEX-AV study was the reduction in RV/LV ratio between baseline and 48 hours post-procedure. The primary safety endpoint was the rate of major adverse events (MAEs), including events such as major bleeding and serious device-related clinical deterioration, pulmonary vascular injury, and cardiac injury, within the first 48 hours. Patients were followed for 30 days post-index procedure.

Clinical Impact and Future Directions

“The 510(k) clearance of the AlphaVac System represents an important milestone towards the treatment of PE,” says Ranade in a release. “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.”

The APEX-AV study showed a mean decrease in the RV/LV ratio from baseline to 48 hours post-procedure of 0.45 (significantly greater than the pre-defined performance goal of 0.12 (p < 0.001)) and a MAEs rate of 4.1% (significantly lower than the pre-defined performance goal of 25% (p < 0.001)). The study also showed 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,” says John M. Moriarty, MD, president-elect of the PERT Consortium and professor of interventional radiology at UCLA, in a release. “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.”

The AlphaVac F1885 System is an emergent first-line device that is currently cleared for the removal of thromboemboli from the venous system and for the treatment of PE. The system includes an ergonomic handle, an 18F cannula with an 85-degree angle, an obturator, and a waste bag assembly. The APEX-AV study was designed to provide safety and efficacy data for a clearance specific to PE.

Photo caption: AlphaVac F1885 System

Photo credit: AngioDynamics Inc