FDA clears blood clot removal system for treating pulmonary embolism
Inquis Medical, a California-based medtech company focused on peripheral vascular treatments, has received U.S. Food and Drug Administration (FDA) clearance for its Aventus Thrombectomy System to be used to treat pulmonary embolism (PE).
The Aventus Thrombectomy System, a next-generation mechanical thrombectomy device, was previously cleared to target blood clots in a patient’s peripheral arteries. This new expanded clearance paves the way for PE patients to be treated using the same technology.
The FDA’s decision was based on data from an investigational device exemption study tracking the safety and effectiveness of the Aventus Thrombectomy System in intermediate-risk PE patients. That study, published in full in JSCAI, included 120 patients enrolled at 22 different sites within the United States.[1] The device was associated with no device-related major adverse events and considerable improvements in right heart strain.
“Treating PE requires both speed and precision,” Mojgan Saadat, co-CEO of Inquis Medical, said in a statement. “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.”
“The FDA’s clearance of the Aventus System marks a major milestone for the company,” added Saadat, co-CEO of Inquis Medical. “It validates the tireless efforts of our team and the deep partnerships we’ve built with our physicians, all focused on solving long-standing challenges in clot removal.”
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.