AngioDynamics’ AlphaVac F18⁸⁵ System Gains the US FDA’s Clearance to Treat Pulmonary Embolism
Shots:
- The US FDA has granted 510(k) Clearance to the company’s AlphaVac F18⁸⁵ System which comprises an ergonomic handle, an 18F cannula with an 85-degree angle, an obturator, and a waste bag assembly
- The approval was based on the data from the APEX-AV trial assessing the safety and efficacy of AlphaVac F18⁸⁵ System as a treatment of confirmed acute, intermediate-risk pulmonary embolism patients (n=122) in the US
- The data demonstrated a mean decrease of 0.45 in the RV/LV ratio and a mean reduction of 35.5% in clot burden from baseline to 48hrs. after the procedure with a 4.1% MAEs rate
Ref: AngioDynamics | Image: AngioDynamics
Related News:- Endovascular Engineering Obtains IDE Approval from the US FDA for its Hēlo Thrombectomy System to Treat Pulmonary Embolism
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
