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Inari Medical Announces First Patient Enrolled in the DEFIANCE Trial, Randomized Controlled Trial Evaluating Clinical Outcomes of the ClotTriever® System in Deep Vein Thrombosis
Source: Nasdaq GlobeNewswire / 12 Jan 2023 08:00:00 America/New_York
IRVINE, Calif., Jan. 12, 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, today announced that the first patient has been enrolled in DEFIANCE, a prospective randomized controlled trial (“RCT”) comparing the clinical outcomes of patients with iliofemoral deep vein thrombosis (“DVT”) treated with the ClotTriever System versus anticoagulation only. The trial is led by Principal Investigators: Dr. Xhorlina Marko, Interventional Radiologist at Beaumont Health; Dr. Steven Abramowitz, Chair of Vascular Surgery at MedStar Health; and Professor Stephen Black, MD, consultant vascular surgeon, Guy's and St. Thomas' Hospital, London.
The first DEFIANCE patient was enrolled by Dr. Abdullah Shaikh, Interventional Radiologist at Allegheny Health Network, Pittsburgh, PA. DEFIANCE will enroll 300 DVT patients at up to 60 centers worldwide. DEFIANCE is Inari’s second RCT, enrolling in parallel to the PEERLESS pulmonary embolism trial.
“We’re thrilled to enroll the first patient and officially kick off this important clinical trial,” said Dr. Shaikh. “ClotTriever is fundamentally different than other DVT treatments. This trial is designed to produce definitive evidence to change standard of care.”
“DEFIANCE is an important step forward and will answer critical questions about how we manage DVT patients,” said Dr. Steven Abramowitz. “Prior RCTs have focused on thrombolytic-based interventions, which have known downsides and limited effectiveness. This ClotTriever RCT is the first to compare lytic-free thrombectomy to anticoagulation for DVT.”
“With six major clinical studies, including two ongoing RCTs, Inari is wholly committed to VTE patients and producing definitive evidence to support our technologies,” said Dr. Thomas Tu, Inari’s Chief Medical Officer. “None of this is possible without the collaboration and dedication of our clinical trial investigators who continually push the field forward in the name of better patient outcomes.”
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.
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Caroline Corner
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