Inquis Medical announced today that the FDA granted expanded 510(k) clearance for its Aventus thrombectomy system.
The expanded clearance means Aventus now has an indication to treat pulmonary embolism (PE). It comes around a month after the Menlo Park, California-based company shared positive study data for Aventus in PE. The study successfully met its primary endpoints, demonstrating safety and efficacy in treating acute intermediate-risk PE patients.
Aventus, a next-generation mechanical thrombectomy platform, features proprietary tissue-sensing technology. It provides operators with real-time information on the tissue composition in contact with the device. The system offers enhanced precision and control during procedures.
The company says it designed Aventus to address the critical limitations of current technologies.
Last year, the system won FDA 510(k) clearance along with Inquis’ blood return system for peripheral indications. The company brought in a $40 million Series B funding round at the end of 2024 as well.
“Treating PE requires both speed and precision,” said Mojgan Saadat, co-CEO of Inquis Medical. “The Aventus platform is the only thrombectomy solution with integrated tissue-sensing technology that enables precision removal of large clot burdens while streamlining blood return and reducing procedural complexity, all in a single, integrated approach.
“Receiving this clearance in record time speaks to the strength of our clinical data, the quality of our regulatory submission, and the incredible work of the Inquis team. We’re thrilled to launch this technology and deliver a state-of-the-art solution to physicians on the front lines of saving lives.”
