This section highlights FDA-related milestones and regulatory updates for drugs developed by AngioDynamics (ANGO).
Over the past two years, AngioDynamics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
AlphaVac, APEX-AV, and NanoKnife. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
AlphaVac - FDA Regulatory Timeline and Events
AlphaVac is a drug developed by AngioDynamics for the following indication: Mechanical Thrombectomy System.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- AlphaVac
- Announced Date:
- September 19, 2024
- Indication:
- Mechanical Thrombectomy System
Announcement
AngioDynamics, Inc announced the launch of the Prospective, Multicenter, Multi-national, Single Arm Trial Evaluating the Efficacy, Safety and long term functional outcomes of percutaneous mechanical aspiration thrombectomy for Treatment of Acute Pulmonary Embolism (PE) using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System (RECOVER-AV).
AI Summary
AngioDynamics, Inc. has launched a new clinical trial called RECOVER-AV to study a new treatment for acute pulmonary embolism (PE). This prospective, multicenter, multinational, single-arm study will evaluate the safety, efficacy, and long-term functional outcomes of using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System on patients with intermediate-risk PE. The trial focuses on measuring how well the device reduces the right ventricular/left ventricular ratio 48 hours after treatment and monitors any major adverse events, such as device-related complications, within seven days. Patients will be followed for 12 months, with key assessments at 30 days, six months, and 12 months. The study aims to provide robust clinical evidence to support the system’s effectiveness in the European market, where PE cases are prevalent, and further advances non-surgical treatment options for this serious condition.
Read Announcement- Drug:
- AlphaVac
- Announced Date:
- May 21, 2024
- Indication:
- Mechanical Thrombectomy System
Announcement
AngioDynamics, Inc. announced European CE Mark approval of the AlphaVac F1885 System for the non-surgical removal of thrombi or emboli from the pulmonary arteries and for the treatment of pulmonary embolism (PE).
AI Summary
AngioDynamics, Inc. has received European CE Mark approval for its AlphaVac F1885 System. This approval allows the device to be used in the non-surgical removal of thrombi or emboli from the pulmonary arteries to treat pulmonary embolism (PE). The system is designed to reduce thrombus burden and improve right ventricular function, offering a much-needed alternative treatment option for patients who experience PE.
By gaining CE Mark approval, the AlphaVac F1885 System can now be introduced in the EU, where PE is more prevalent and often results in higher patient acuity compared to other regions. The system features an ergonomic handle, an 18F cannula with an 85-degree angle, an obturator, and a waste bag assembly, making it a reliable and innovative tool for healthcare professionals across Europe.
Read Announcement- Drug:
- AlphaVac
- Announced Date:
- May 6, 2024
- Indication:
- Mechanical Thrombectomy System
Announcement
AngioDynamics, Inc announcedthat results from the Acute Pulmonary Embolism Extraction Trial with the AlphaVac System (APEX-AV) were presented at The Society for Cardiovascular Angiography & Interventions (SCAI) 2024 Scientific Sessions hosted in Long Beach, California on May 3, 2024.
AI Summary
AngioDynamics, Inc. announced important results from its Acute Pulmonary Embolism Extraction Trial using the AlphaVac System (APEX-AV). The trial results were presented at the Society for Cardiovascular Angiography & Interventions (SCAI) 2024 Scientific Sessions held in Long Beach, California on May 3, 2024. The study focused on evaluating the AlphaVac System for removing blood clots in patients with acute pulmonary embolism, a life-threatening condition. According to the data shared at the conference, the AlphaVac System showed promise in effectively extracting clots, offering a new option in the treatment of this severe condition. These findings could help improve patient outcomes and contribute to safer, more efficient procedures in emergency cardiovascular care. AngioDynamics is planning further studies based on these results, which are seen as a significant advance in treatment options for acute pulmonary embolism cases.
Read Announcement
APEX-AV - FDA Regulatory Timeline and Events
APEX-AV is a drug developed by AngioDynamics for the following indication: For Acute Pulmonary Embolism.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- APEX-AV
- Announced Date:
- January 13, 2025
- Indication:
- For Acute Pulmonary Embolism
Announcement
AngioDynamics, Inc announced the publication of the results from the Acute Pulmonary Embolism Extraction Trial with the AlphaVac System (APEX-AV) in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI).
AI Summary
AngioDynamics, Inc. recently announced that the results from its Acute Pulmonary Embolism Extraction Trial with the AlphaVac System (APEX-AV) have been published in the Journal of the Society for Cardiovascular Angiography & Interventions. The study focused on treating pulmonary embolism by reducing the clot burden, and the findings were impressive. Researchers observed a 35.5% reduction in clot burden using the AlphaVac F1885 System, demonstrating the device’s safety, efficacy, and efficiency. The trial, which involved patients with acute intermediate‐risk pulmonary embolism, also showed significant improvements in the heart’s right ventricle to left ventricle (RV/LV) ratio within 48 hours post-procedure, while reporting a low rate of adverse events. Publishing in a peer-reviewed journal underscores the potential of the AlphaVac System to enhance patient outcomes and provides physicians with a reliable tool for timely treatment of this life-threatening condition.
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NanoKnife System - FDA Regulatory Timeline and Events
NanoKnife System is a drug developed by AngioDynamics for the following indication: Treating men with unifocal intermediate-risk prostate cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NanoKnife System
- Announced Date:
- December 9, 2024
- Indication:
- Treating men with unifocal intermediate-risk prostate cancer
Announcement
AngioDynamics, Inc announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for the NanoKnife System for prostate tissue ablation.
AI Summary
AngioDynamics, Inc. announced that it has received FDA 510(k) clearance for its NanoKnife System to ablate prostate tissue. This clearance came after the pivotal PRESERVE clinical study, which focused on evaluating the safety and effectiveness of the NanoKnife System in patients with intermediate-risk prostate cancer.
The clinical study, conducted with 121 patients at 17 sites, confirmed that the system could ablate prostate tissue while preserving essential functions such as urinary continence and erectile capability. The NanoKnife System uses non-thermal irreversible electroporation technology to target prostate tissue selectively, offering a minimally invasive alternative to traditional treatments. AngioDynamics’ CEO, Jim Clemmer, stated that this FDA clearance is a significant milestone towards establishing the NanoKnife System as a standard treatment option for prostate tumors, potentially enhancing patient outcomes and overall quality of life.
Read Announcement
