AngioDynamics Launches APEX-AV Study in Partnership with PERT Consortium

April 27, 2022—AngioDynamics, Inc. announced the launch of APEX-AV, the “Acute Pulmonary Embolism Extraction Trial with the AlphaVac System” clinical study, which is aimed at evaluating the efficacy and safety of the company’s AlphaVac multipurpose mechanical aspiration (MMA) F18⁸⁵ system in the treatment of acute intermediate-risk pulmonary embolism (PE).

AngioDynamics advised it initiated the APEX-AV study in partnership with the Pulmonary Embolism Response Team (PERT) Consortium.

According to the company, this single-arm study will be led by co-Principal Investigators William Brent Keeling, MD, and Mona Ranade, MD. Dr. Keeling is Associate Professor of Surgery, Department of Surgery, at the Emory University School of Medicine in Atlanta, Georgia, and is President of the PERT Consortium. Dr. Ranade is Interventional Radiologist at UCLA Health in Los Angeles, California, and Assistant Professor at Mount Sinai Health System in New York, New York.

APEX-AV is a single-arm investigational device exemption study that will enroll patients with confirmed acute, intermediate-risk PE at up to 20 hospital-based sites in the United States. Patient enrollment is anticipated to commence in the summer of 2022.

The primary efficacy endpoint of the APEX-AV study is the reduction in right ventricle/left ventricle ratio between baseline and 48 hours post procedure. The primary safety endpoint is the rate of major adverse events, including device-related death and major bleeding within the first 48 hours. Patients will be followed for 30 days post index procedure.

“The APEX-AV study represents an important trial in the PE space,” commented Dr. Keeling in AngioDynamics’ press release. “It will hopefully add to the growing body of literature substantiating catheter-based embolectomy as a safe and efficacious treatment for patients with intermediate-risk PE.”

Dr. Ranade added, “The APEX-AV study evaluates the safety and efficacy of the new AlphaVac F18⁸⁵ system in intermediate-risk PE patients. Generating high-level data on PE treatment is of extreme importance. I am optimistic that the APEX-AV study will significantly contribute to the growing evidence in the treatment of PE, thereby advancing patient care.”

The company noted that the AlphaVac MMA system is designed as an off-the-shelf, easy to assemble, emergent first-line device for the removal of thromboemboli from the venous system. The system includes an ergonomic handle, an 18-F cannula with an 85º angle, an obturator, and a waste bag assembly.

The AlphaVac MMA F18⁸⁵ PE system when used for the treatment of PE is an investigational device, limited by United States law to investigational use, noted AngioDynamics.