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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