Inari Medical Enrolls First Patient in PEERLESS II Trial Evaluating FlowTriever for Intermediate-Risk Pulmonary Embolism

Inari Medical Announces First Patient Enrolled in PEERLESS II Clinical Trial for FlowTriever. This prospective, global, multicenter randomized controlled trial (RCT) compares outcomes in moderately ill acute pulmonary embolism (PE) patients treated with the FlowTriever system versus those receiving conventional anticoagulation therapy alone.

The first patient was recruited by William H Matthai Jr (Penn Presbyterian Medical Center, University of Pennsylvania, Philadelphia, US). Matthai stated, "PEERLESS II is challenging the world's most commonly used first-line therapy for PE. Despite advancements in mechanical thrombectomy, anticoagulation alone remains the standard of care. This trial aims to generate definitive evidence to influence PE treatment guidelines globally."

According to Inari Medical, PEERLESS II is the largest study of its kind and will include up to 1,200 randomized patients across 120 global centers. The study is being conducted alongside the currently enrolling PEERLESS RCT, which compares FlowTriever with catheter-directed thrombolysis. Both trials aim to generate high-quality clinical evidence needed to advance the field and establish FlowTriever as the optimal therapy for intermediate-risk PE patients.

Inari Chief Medical Officer Thomas Tu stated: "Inari is actively recruiting for three randomized controlled trials: PEERLESS, PEERLESS II, and DEFIANCE, demonstrating our unwavering commitment to guideline-changing research aimed at ultimately improving patient outcomes. With the dedication of our committed researchers, we look forward to accelerating enrollment, bringing us closer to changing the standard of care."

Flow Triever is a catheter-based thrombectomy medical device designed to eliminate clots in peripheral vessels. Flow Triever consists of three parts: the FlowTriever Catheter (FTC), Aspiration Guide Catheter (AGC), and Retraction Aspirator (RA). Through continuous research and optimization, Inari Medical has further expanded the intended use of Flow Triever. Mechanical thrombectomy can quickly remove emboli without the use of thrombolytic agents, relieve right ventricular pressure, and improve clinical symptoms, but its safety and effectiveness still require a large amount of experimental data for validation.

The FlowTriever system is a large-bore catheter-based mechanical thrombectomy device that mechanically engages thrombus in the pulmonary artery through a self-expanding nitinol mesh. As the large-bore catheter aspirates, the nitinol mesh retracts into the catheter, entrapping the thrombus. The FlowSaver filters the aspirated thrombus and blood for return to the patient, minimizing blood loss and enabling bloodless thrombectomy during pulmonary embolism (PE) procedures.

Inari Medical was founded in July 2011 in Delaware, with its headquarters located in Irvine, California. It is a commercial-stage medical device company dedicated to the development, manufacturing, and sale of interventional treatment devices for venous diseases. In May 2020, Inari Medical was listed on the NASDAQ stock exchange in the United States under the ticker symbol NARI, with Bank of America and Morgan Stanley acting as the joint bookrunners for the transaction. Inari Medical focuses on developing innovative catheter-based technologies to treat venous thromboembolism, aiming to safely remove large amounts of clots from major blood vessels without the use of thrombolytic drugs. Inari Medical has developed two minimally invasive, mechanical thrombectomy technology platforms: Flow Triever and Clot Triever. Clot Triever is used to remove clots from peripheral blood vessels and treat patients with deep vein thrombosis, while Flow Triever is used to treat pulmonary embolism.

The technical opinions in this article do not represent the views of CCI.

Planning: Shen Li/Editor: Chen Baolin

Author: Yun Ye Xuan /Production: Wang Rui