Innovation & TechAngioDynamics Completes PE Trial Enrollment for AlphaVac System

AngioDynamics Completes PE Trial Enrollment for AlphaVac System

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ALBANY, NY – AngioDynamics, a prominent medical technology company dedicated to enhancing blood flow, expanding cancer treatment options, and improving patient quality of life, has successfully concluded patient enrollment in the Acute Pulmonary Embolism Extraction Trial with the AlphaVac System (APEX-AV). This clinical study focuses on assessing the safety and efficacy of AngioDynamics’ AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System in treating acute intermediate-risk pulmonary embolism (PE).

Moreover, Pulmonary embolism ranks as the third-leading cause of cardiovascular mortality in the United States. The completion of the APEX-AV Study signifies a significant stride in expanding treatment options and enhancing care for patients grappling with pulmonary embolism. The trial enrolled 122 patients with confirmed acute, intermediate-risk PE across 25 hospital-based sites in the United States.

“The completion of the APEX-AV Study to assess the performance of the AlphaVac F1885 System in reducing thrombus burden and improving right ventricular function is a meaningful step toward expanding treatment options and improving care for patients with pulmonary embolism,” said Juan Carlos Serna, AngioDynamics’ Senior Vice President of Clinical and Scientific Affairs. “We thank The PERT Consortium™, including our enrolling partners, for its commitment to generating robust clinical evidence to help address the needs of this patient population.”

The primary efficacy endpoint of the APEX-AV Study is the reduction in RV/LV ratio between baseline and 48 hours post-procedure, while the primary safety endpoint is the rate of Major Adverse Events (MAEs) within the first 48 hours. Patients will be monitored for 30 days post-index procedure.

“The completion of the APEX-AV Study represents an important milestone in the catheter-directed therapies CDT space for the treatment of pulmonary embolism. I sincerely thank all the investigators for their commitment and dedication,” said 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™.

“Data from the APEX-AV study expands the current body of literature on the safety and efficacy of mechanical thrombectomy and broadens the PE treatment options, particularly in this space,” said Mona Ranade, MD, Assistant Professor, Interventional Radiology, at the David Geffen School of Medicine at UCLA.

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Furthermore, Pulmonary embolism affects around 900,000 people in the United States annually and can be life-threatening. Patients with submassive or intermediate-risk PE, representing a significant portion of those hospitalized, have a mortality rate of 3 to 14%. The APEX-AV Study contributes valuable insights to enhance treatment outcomes in this critical area of healthcare.

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