Inari Medical’s ClotTriever System Will Be Evaluated to Treat DVT in DEFIANCE Trial

August 30, 2022—Inari Medical, Inc. announced the planned enrollment of the DEFIANCE randomized controlled trial (RCT). The trial will compare clinical outcomes of patients with iliofemoral deep vein thrombosis (DVT) treated with the company’s ClotTriever system versus treatment with anticoagulation only. The trial will enroll 300 patients at up to 60 centers worldwide.

According to the company, the ClotTriever system received FDA 510(k) clearance and European CE Mark approval for the nonsurgical removal of clot from peripheral blood vessels, including for use in the treatment of DVT.

Steven Abramowitz, MD, and Xhorlina Marko, MD, are coprincipal investigators of the DEFIANCE trial. Dr. Abramowitz is Chair of Vascular Surgery at MedStar Heath in Washington, DC. Dr. Marko is an interventional radiologist at Beaumont Health in Dearborn, Michigan.

“DEFIANCE is the first RCT to compare mechanical thrombectomy to anticoagulation for the treatment of DVT,” commented Dr. Marko in the Inari press release. “The primary endpoint for the trial is a hierarchical composite of treatment failure and postthrombotic syndrome (PTS) severity at 6 months. The trial has the potential to influence guidelines and change the standard of care.”

Dr. Abramowitz advised in the press release, “Anticoagulation is still the predominant therapy used in the management of DVT and in some studies has been associated with PTS in up to 50% of patients.”

He further stated, “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, which is Inari’s second RCT, will run in parallel to the PEERLESS trial that is comparing FlowTriever to catheter-directed thrombolytics in pulmonary embolism, noted the company.

The commencement of enrollment in PEERLESS was announced in February 2022. The FlowTriever system received 510(k) clearance and CE Mark approval for the nonsurgical 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, advised Inari.