Inari Medical Announces Randomized Controlled Trial Evaluating Clinical Outcomes of the ClotTriever® System in Deep Vein Thrombosis
DEFIANCE is a randomized controlled trial (RCT) comparing the clinical outcomes of patients with iliofemoral deep vein thrombosis (DVT) treated with the ClotTriever System versus anticoagulation only.
IRVINE, Calif., Aug. 30, 2022 (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 DEFIANCE trial.
DEFIANCE is a 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 will enroll 300 patients at up to 60 centers worldwide. DEFIANCE is Inari’s second RCT and it will run in parallel to the PEERLESS trial. PEERLESS commenced earlier this year and compares FlowTriever to catheter-directed thrombolytics in pulmonary embolism.
“Anticoagulation is still the predominant therapy used in the management of DVT and in some studies has been associated with post-thrombotic syndrome (PTS) in up to 50% of patients,” said Dr. Steven Abramowitz, Co-Principal Investigatory and Chair of Vascular Surgery at MedStar Heath. “PTS is a debilitating condition with symptoms including swelling, difficulty walking, skin changes and poorly healing open wounds. Research has shown PTS quality of life scores can be as low as those of patients suffering from heart failure or cancer. Mechanical thrombectomy procedures, using technology like ClotTriever, rapidly remove large volumes of DVT and may thereby reduce the risk of PTS.”
“DEFIANCE is the first RCT to compare mechanical thrombectomy to anticoagulation for the treatment of DVT,” said Dr. Xhorlina Marko, Co-Principal Investigator and Interventional Radiologist at Beaumont Health. “The primary endpoint for the trial is a hierarchical composite of treatment failure and PTS severity at 6 months. The trial has the potential to influence guidelines and change the standard of care.”
“Physicians need to know in which patients to use our devices and what outcomes to expect. This is our basic responsibility,” said Dr. Thomas Tu, Inari’s Chief Medical Officer. “We have studied over 2,000 patients, published 250 peer reviewed publications, and DEFIANCE marks our 6th major clinical study. These high-quality studies will establish a new standard of care for patients and further distance us from competition.”
About Inari Medical, Inc.
Inari Medical, Inc. is a medical device company with a mission to treat and transform the lives of patients suffering from venous and other diseases. Our current product offering consists of two minimally invasive, novel catheter-based mechanical thrombectomy devices that are designed to remove large clots from large vessels and eliminate the need for thrombolytic drugs. The company purpose-built its products for the specific characteristics of the venous system and the treatment of the two distinct manifestations of venous thromboembolism, or VTE: deep vein thrombosis and pulmonary embolism. The ClotTriever system is 510(k)-cleared by FDA and CE marked for the non-surgical removal of clot from peripheral blood vessels, including for the use in the treatment of deep vein thrombosis. The FlowTriever system is 510(k)-cleared by FDA and CE marked for the non-surgical removal of clot from peripheral blood vessels, including for the use in the treatment of pulmonary embolism and clot in transit in the right atrium.
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