Inquis Medical Reports the US FDA’s 510(k) Clearance of AVENTUS Thrombectomy System to Treat Pulmonary Embolism
Shots:
- The US FDA has granted 510(k) clearance to the AVENTUS Thrombectomy System for the treatment of pulmonary embolism (PE), expanding its prior clearance for use in the peripheral vasculature
- AVENTUS was evaluated in a completed pivotal IDE trial for aspiration thrombectomy with filtered blood reinfusion in intermediate-risk PE pts, which showed rapid improvement in right heart strain & favorable safety across various clinical settings; data was presented at SCAI 2025 & published in The JSCAI
- AVENTUS Thrombectomy System uses real-time tissue-sensing to guide precise clot removal &, when combined with the FDA-cleared AVENTUS Clot Management System, allows filtered reinfusion of aspirated blood for the treatment of pulmonary embolism
Ref: GlobeNewswire | Image: Inquis Medical | Press Release
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