Business
AngioDynamics Completes Patient Enrollment in APEX-AV Study Assessing AlphaVac F18⁸⁵ System in Treatment of Pulmonary Embolism
122 Patients Enrolled in Single-arm IDE Study; 30-Day Follow-up LATHAM, N.Y.--(BUSINESS WIRE)-- AngioDynamics, Inc. (NASDAQ: ANGO), a leading and
About this update from Angiodynamics, Inc.
[{"type":"text","content":"\n122 Patients Enrolled in Single-arm IDE Study; 30-Day Follow-up\n\n\n LATHAM, N.Y.--(BUSINESS WIRE)--\nAngioDynamics, 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 the completion of patient enrollment in the Acute Pulmonary Embolism Extraction Trial with the AlphaVac System (APEX-AV). APEX-AV is a clinical study aimed at evaluating the safety and efficacy of the Company’s AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System in the treatment of acute intermediate-risk pulmonary embolism (PE).\n\n\nPE represents the third-leading cause of cardiovascular mortality in the United States.1\n\n\n“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.”\n\n\nAPEX-AV is 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. The primary efficacy endpoint of the APEX-AV Study is the reduction in RV/LV ratio between baseline and 48 hours post-procedure. The primary safety endpoint is the rate of Major Adverse Events (MAEs), including device-related death and major bleeding within the first 48 hours. Patients will be followed for 30 days post-index procedure.\n\n\n“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™.\n\n\nAngioDynamics initiated the APEX-AV Study in partnership with ...