The CLEAR Aspiration System incorporates three distinct modes: cyclical, uniform, and a blood-saving aspiration setting. The platform includes a specialized pump alongside single-use disposables, specifically the INSERA Catheter, aspiration tubing, and a collection canister. This regulatory milestone follows extensive safety and performance evaluations, including in vivo studies and rigorous software and biocompatibility validation.
Insera Therapeutics Secures FDA Clearance for CLEAR Aspiration System
Dallas-based Insera Therapeutics has received U.S. FDA 510(k) clearance for its CLEAR Aspiration System, a digital platform designed to remove emboli and thrombi from peripheral vessels. The approval validates the company's proprietary cyclical aspiration technology, which now joins its existing CE Mark authorization for the European market.
Company leadership highlighted the system's development as a culmination of over a decade of research. Insera holds a global portfolio of 108 patents related to cyclical aspiration, with foundational priority dating back to 2013. Clinical experts, including Dr. Mahmood Razavi and Dr. Italo Linfante, noted that the integration of digital, cyclical vacuum technology represents a significant evolution in peripheral mechanical thrombectomy. The system is designed to provide clinicians with more precise control during the extraction of blood clots from both arterial and venous systems.
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