Item 8.01. Other Events

On November 13, 2020, Inari Medical, Inc. (the "Company") announced positive follow-up results from the first 230 patients enrolled in its FlowTriever All-Comer Registry for Patient Safety and Hemodynamics, or FLASH registry. The FLASH registry is a prospective, multicenter registry designed to evaluate real-world patient outcomes after treatment of pulmonary embolism, or PE, including high- and intermediate-risk patients, with FlowTriever.

These follow-up results follow the positive results from the first 230 patients enrolled in the FLASH registry that were previously reported on October 19, 2020 and extend the study follow-up period to 30 days after treatment with FlowTriever. At 30 days, one death (0.4%) was reported and the results showed a readmission rate of 6.7%. In contrast, the national PERT Consortium Quality Database recently showed 30-day mortality rates of 25.9% and 6.1% for high- and intermediate-risk PE patients and a readmission rate of nearly 25%. Efficacy data was also positive and showed normalization or near normalization in a battery of hemodynamic variables, such as pulmonary artery pressure, RV/LV ratio and heart rate, as well as dyspnea (shortness of breath) metrics.

FLASH Registry

The FLASH registry is a prospective, multicenter registry designed to evaluate real-world patient outcomes after treatment of pulmonary embolism, or PE, and capture several acute and longer-term outcome measures. We plan to enroll up to 500 patients with high- and intermediate-risk PE across the United States. The primary outcome measure is the composite of patients that experience major adverse events, including device-related death, major bleeding, or device or procedure-related adverse events, in the 48 hours after treatment using the FlowTriever. Secondary safety outcomes include the rate of patients with individual components of composite major adverse events in the 48 hours after treatment and the rates of death and device-related serious adverse events within 30 days of treatment. Secondary effectiveness outcomes include change in pulmonary artery pressures, changes in a range of on-table hemodynamic measurements and utility measures, such as length of stay in the ICU and hospital. In addition, there are follow-up visits for patients at up to six months from the date of treatment.

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