IRVINE, Calif., May 22, 2023 (GLOBE NEWSWIRE) -- Inari Medical, Inc. (NASDAQ: NARI) (“Inari”) a medical device company with a mission to treat and transform the lives of patients suffering from venous and other diseases, announced planned enrollment of the PEERLESS II trial, Inari’s third randomized controlled trial (RCT) in venous thromboembolism (VTE). The trial design was presented at the Society for Cardiovascular Angiography & Interventions (SCAI) 2023 Scientific Sessions.
PEERLESS II is a prospective, global, multi-center RCT comparing the outcomes of intermediate-risk pulmonary embolism (PE) patients treated with the FlowTriever system versus anticoagulation alone. The study will include up to 1,200 patients and up to 100 global centers. The trial is led by Global Principal Investigators (PIs): Dr. Jay Giri, Cardiovascular Catheterization Laboratories Associate Director and Assistant Professor of Medicine at the Hospital of University of Pennsylvania; and Dr. Frances Mae West, Associate Professor of Medicine and Program Director of the Division of Pulmonary & Critical Care Medicine Fellowship at Thomas Jefferson University in Philadelphia, PA; and European PIs: Prof. Felix Mahfoud, Leading Senior Consultant at Department of Internal Medicine and Cardiology, University Hospital Saarland; and Prof. Bernhard Gebauer, Head of Section Interventional Radiology, University Hospital Charité.
“PEERLESS II is a groundbreaking trial in terms of its robust size, randomized design and potential to shape PE treatment guidelines,” said Dr. Giri. “The primary outcome for the trial is a hierarchical composite of clinical outcomes including mortality, clinical deterioration, hospital re-admission, and dyspnea. These meaningful endpoints go beyond historical surrogate measures such as RV/LV ratio to definitively answer critical questions about intervention in PE with the FlowTriever system.”
“Conservative treatment with anticoagulation alone has been the guideline recommended practice for intermediate-risk PE for decades, and outcomes in PE patients have remained consistently poor,” said Dr. West, who is also a Board Member on the PERT Consortium. “With the availability of new purpose-built tools for PE thrombectomy, it is time we begin to think more critically about whether a conservative approach to PE should remain standard of care. PEERLESS II was designed by a multi-specialty global steering committee to answer this important question.”
“PEERLESS II will build off Inari’s FLASH registry, the largest prospective registry ever conducted in PE thrombectomy evaluating the FlowTriever System in 1,000 patients,” said Dr. Thomas Tu, Inari’s Chief Medical Officer. “With over 1,700 patients across PEERLESS and PEERLESS II, Inari is now set to enroll more PE RCT patients than all industry and non-industry RCTs combined. Inari’s three RCTs in VTE all aim to study meaningful, patient-centric clinical endpoints. We are thankful for the partnership of our Steering Committee and the commitment of our investigators dedicated to generating high quality clinical evidence.”
About Inari Medical, Inc.
Patients first. No small plans. Take care of each other. These are the guiding principles that form the ethos of Inari Medical. We are committed to improving lives in extraordinary ways by creating innovative solutions for both unmet and underrecognized health needs. In addition to our purpose-built products, we leverage our capabilities in education, clinical research, and program development to improve patient outcomes. We are passionate about our mission to establish our treatments as the standard of care for venous thromboembolism and beyond. We are just getting started.