Inari Partners with AVF and NBCA on DEFIANCE RCT Enrollment

October 15, 2024—Inari Medical, Inc. announced a partnership with the American Venous Forum (AVF) and the National Blood Clot Alliance (NBCA) on the DEFIANCE randomized controlled trial (RCT).

AVF will collaborate with Inari to help create awareness of the DEFIANCE RCT and assist with enrollment through its members and stakeholders. 

DEFIANCE is a prospective, multinational RCT that will evaluate and compare clinical outcomes in patients with deep vein thrombosis (DVT) treated with Inari’s ClotTriever system versus anticoagulation alone.

“Our team is immensely proud to partner with two leading organizations representing patients and specialists—the largest national patient advocacy organization and a renowned global venous medical society, a testament to the importance of high-quality RCTs in this space,” stated Thomas Tu, MD, Inari’s Chief Medical Officer, in the company’s press release.

AVF President Ruth Bush, MD, commented in the press release, “AVF members pledge to practice evidence-based medicine, participate in scientific knowledge, and provide accurate information, so we commend Inari for their commitment to contributing high-quality evidence by conducting the first RCT for the use of mechanical thrombectomy in patients with DVT, comparing treatment with the ClotTriever system versus anticoagulation.”

Dr. Bush continued, “Early intervention with current mechanical thrombectomy devices has been widely adopted by our members, and since this treatment modality was introduced after DVT guidelines were last updated in 2012, this study is of great interest to our multidisciplinary global community of venous experts.”

NBCA President and Board Chair, Leslie Lake, added, “The vast majority of DVT survivors in the NBCA community were treated with the current standard of care, anticoagulation, and too many have developed the debilitating symptoms of postthrombotic syndrome, with swollen legs, difficulty walking, skin changes, and poorly healing open wounds. NBCA commends Inari Medical for investing in DEFIANCE, a much-needed landmark trial with the potential to impact future treatment guidelines for DVT patients.”

In January 2023, Inari announced commencement of the DEFIANCE trial, which will enroll 300 DVT patients at up to 60 centers worldwide. The ClotTriever system has 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.