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Inari Medical, Inc. (NASDAQ:NARI) ("Inari") a medical device company focused on developing products to treat and transform the lives of patients suffering from venous and other diseases, announced positive two-year interim results from the CLOUT registry. The data was presented at the American Venous Forum meeting by principal investigator, David Dexter, MD, FACS, a vascular surgeon at Sentara Vascular Specialists in Norfolk, Virginia.
The interim results are the largest prospective, multi-center two-year dataset in deep vein thrombosis (DVT) since the ATTRACT trial and confirm the excellent safety, effectiveness, and long-term outcomes of the ClotTriever system in real-world DVT patients. Patients had low incidence of independently adjudicated safety events related to rethrombosis, with only 5.0% and 8.4% at 30-days and 6 months, respectively. In the interim analysis, 228 patients completed their two-year follow-up visit. Patients had significant and sustained improvement in post-thrombotic syndrome (PTS) over the follow-up period, with only 7.3% moderate-severe PTS at two years. 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 18-24%.
"With third-party adjudication of all safety events in this robust, large dataset, ClotTriever has a strong safety profile. And the longer-term results are suggestive of sustained benefit through a critical window when longer-term sequalae typically manifest in DVT patients," said Dr. Dexter. "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."
"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," said Dr. Thomas Tu, Inari's Chief Medical Officer. "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 vs. anticoagulation alone. No other company is pursuing this level of research in VTE. In the treatment of DVT, clinical data does matter. We remain committed to establishing the ClotTriever and FlowTriever systems as standard of care for deep vein thrombosis and pulmonary embolism (PE) patients."
PTS Rates in Context:
| ClotTriever CLOUT Registry Interim results (n=228) |
ATTRACT Anticoagulation Arm (n=236) |
ATTRACT Intervention Arm (n=258) | CAVA Anticoagulation Arm (n=58) | CAVA Intervention Arm (n=62) | |
| 2-Year PTS | 19.9% | 36.0% | 30.6% | 44.8%* | 30.6%* |
| 2-Year Moderate-Severe PTS | 7.3% | 24.0% | 18.2% | 24.1%* | 22.6%* |
*Median follow-up 39.0 months
Posted In: NARI
