AngioDynamics, Inc. has obtained CE Mark approval in Europe for its AlphaVac F1885 System, enabling the non-surgical removal of blood clots from pulmonary arteries and the treatment of pulmonary embolism (PE).

This approval marks a significant advancement in patient care and safety for endovascular therapies within the European Union, which experiences a higher prevalence of PE compared to the United States. With an estimated 435,000 PE events occurring annually in the EU’s six most prominent countries, the AlphaVac F1885 System offers healthcare providers an additional tool.

The system aids in reducing blood clot burden and improving right ventricular function in PE patients. Clinical trial results from the APEX-AV study demonstrated a substantial reduction in the clot burden and a favorable Major Adverse Event rate. The mean procedure time was approximately 37 minutes.

The AlphaVac F1885 System consists of an ergonomic handle, an 18F cannula with an 85-degree angle, an obturator, and a waste bag assembly. AngioDynamics continues to innovate and expand its global reach, providing cutting-edge solutions to combat PE and enhance patient outcomes.

Source link: http://www.businesswire.com/news/home/20240521113985/en/AngioDynamics-Announces-CE-Mark-Approval-in-Europe-for-AlphaVac-F18%E2%81%B8%E2%81%B5-System

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