Inari Medical’s FlowTriever Evaluated in Interim Data From FLASH Registry of Pulmonary Embolism Patients

October 28, 2021—Inari Medical, Inc. announced positive acute and long-term interim results from the first 500 pulmonary embolism (PE) patients enrolled in FLASH, the FlowTriever Outcomes Registry.

FLASH is a prospective, multicenter, single-arm registry evaluating real-world patient outcomes after treatment of PE with FlowTriever. The 500-patient interim results were presented on October 27 via webcast at TCT 2021 by principal investigator Catalin Toma, MD, an Interventional Cardiologist at the University of Pittsburgh Medical Center in Pittsburgh, Pennsylvania. TCT 2021, the Transcatheter Cardiovascular Therapeutics conference, will be held in-person and broadcast live online November 4-6 in Orlando, Florida.

According to Inari Medical, at 48 hours postprocedure, the major adverse event rate and mortality rate were low, at 1.4% and 0.2%, respectively. None of the deaths or major adverse events were device-related. Collectively, these PE patients experienced substantial on-table improvements in hemodynamics and symptoms, which translated to 6-month improvements in cardiac function, functional status, and quality of life measures.

The company noted that the outcomes were achieved while limiting utilization of hospital resources, with < 4% of patients receiving adjunctive therapy and a median of 0 days postprocedure in the intensive care unit.

“These interim results reinforce the strong safety profile of the FlowTriever system in real-world PE patients, with substantial on-table clinical improvements and immediate symptom relief,” commented Dr. Toma in Inari Medical’s press release. “We believe these 6-month follow-up data suggest that removal of clot burden without the risks of lytics has potential positive long-term implications for PE patients, including strikingly low rates of hospital readmissions, dyspnea, chronic thromboembolic disease, and chronic thromboembolic pulmonary hypertension. These data suggest that treatment with FlowTriever may fundamentally improve the natural course of the disease, and that is tremendously exciting.”

Inari Medical’s FlowTriever system has received FDA 510(k) clearance and European CE Mark approval for the nonsurgical removal of clot from peripheral blood vessels, including for the use in the treatment of PE and clot in transit in the right atrium.