AngioDynamics has received FDA clearance for the AlphaVac F1885 System to treat pulmonary embolism (PE), a life-threatening condition. PE affects a significant portion of the population and is a leading cause of cardiovascular deaths.

Expanding the AlphaVac F1885 System’s indication enhances its use in critical medical settings. The system offers a non-surgical option for removing blood clots from veins, reducing the patient’s thrombus burden, and improving right ventricular function.

The APEX-AV study’s results supported the FDA approval, which demonstrated the device’s effectiveness and safety in treating PE. The study, conducted in partnership with the Pulmonary Embolism Response Team (PERT) Consortium, enrolled 122 patients and showed a significant reduction in clot burden and improved patient outcomes.

Adding the AlphaVac System to the mechanical thrombectomy landscape significantly advances PE treatment. Its user-friendly design, proven efficacy, and favorable safety profile provide physicians with valuable tools for improving patient care.

Juan Carlos Serna, Senior Vice President of Scientific and Clinical Affairs at AngioDynamics, emphasized the company’s commitment to patient-centered solutions and merging clinician expertise with outcome-driven therapies. Dr. William Brent Keeling, co-principal Investigator of the APEX-AV study, highlighted the critical role of the AlphaVac System in the treatment of PE patients.

This FDA clearance marks a milestone in the fight against PE, providing a safe and effective option for improving patient outcomes and reducing mortality associated with this condition.

Source link: http://www.businesswire.com/news/home/20240404798384/en/AngioDynamics-Receives-510-k-Clearance-for-AlphaVac-F1885-System-in-Treatment-of-PE

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Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.