AngioDynamics Receives 510(k) Clearance for AlphaVac F1885 System in Treatment of PE - Seite 2

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

“The 510(k) clearance of the AlphaVac System represents an important milestone towards the treatment of PE,” said Mona Ranade, MD, Assistant Professor, Interventional Radiology, at the David Geffen School of Medicine at UCLA. “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.⁴

“Catheter-based therapies are becoming a major tool in the PE space,” said John M. Moriarty, MD, President-elect, The PERT Consortium^TM, Professor, Interventional Radiology, 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.”

About the AlphaVac F18⁸⁵ System

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. For risk information, visit https://bit.ly/Angio-risk-info.