Inari Announces 2-Year Interim Data From CLOUT DVT Registry

March 12, 2024—Two-year interim data from Inari Medical, Inc.’s CLOUT registry were recently presented, which the company says confirm the safety, effectiveness, and long-term outcomes of the ClotTriever system in real-world deep vein thrombosis (DVT) patients. In the interim analysis, 228 patients completed their 2-year follow-up visits.

The CLOUT results showed patients had a low incidence of independently adjudicated safety events related to rethrombosis with 5.0% at 30 days and 8.4% at 6 months.

Principal Investigator David Dexter, MD, a vascular surgeon at Sentara Vascular Specialists in Norfolk, Virginia, presented the data at Venous 2024, the annual meeting of the American Venous Forum held March 3-6 in Tampa, Florida. The findings represent the largest prospective, multicenter 2-year data set in DVT since the National Institute of Health’s ATTRACT trial, noted the company.

According to Inari Medical, patients had significant and sustained improvement in postthrombotic syndrome (PTS) during the follow-up period, with 7.3% moderate-severe PTS at 2 years. The company stated that the PTS rates reported in CLOUT are significantly lower than those from historical DVT studies such as ATTRACT and CAVA, which reported moderate-severe PTS rates ranging from 18% to 24%.

“With third-party adjudication of all safety events in this robust, large dataset, ClotTriever has a strong safety profile,” commented Dr. Dexter in the company’s press release. “And the longer-term results are suggestive of sustained benefit through a critical window when longer-term sequalae typically manifest in DVT patients. The low PTS rate that continues to improve over time is a testament to the safety and effectiveness of wall-to-wall thrombus removal with ClotTriever.”

Thomas Tu, MD, who is Inari’s Chief Medical Officer, added. “This data continues to reinforce the strong safety and effectiveness profile of the ClotTriever system, which is not only the most utilized, but also the most studied thrombectomy device in DVT.”

Dr. Tu continued, “We are committed to generating best-in-class clinical data. This includes our currently enrolling randomized controlled trial, DEFIANCE, which will compare outcomes after ClotTriever treatment versus anticoagulation alone. No other company is pursuing this level of research in venous thromboembolism. In the treatment of DVT, clinical data does matter. We remain committed to establishing the ClotTriever and FlowTriever systems as standard of care for DVT and pulmonary embolism patients.”