Inari Medical’s FlowTriever System Studied in FLAME Trial for Treatment of High-Risk PE

March 6, 2023—Inari Medical, Inc. announced results from the prospective FLAME study of the interventional treatment of high-risk/massive pulmonary embolism (PE) with the company’s FlowTriever system.

The FLAME investigators compared the outcomes of patients treated with FlowTriever versus those treated with other therapies in a context arm. The study was stopped early because of overwhelmingly positive outcomes in the FlowTriever patients, noted the company.

Mitchell Silver, DO, and James Horowitz, MD, are the national principal investigators for the FLAME study.

Dr. Silver presented the data during the Clinical and Investigative Horizons session at ACC.23/WCC, the American College of Cardiology’s annual scientific session together with the World Congress of Cardiology held March 4-6, 2023, in New Orleans, Louisiana.

According to Inari Medical, the study’s primary endpoint measured a composite of in-hospital clinical outcomes, including mortality, major bleeding, clinical deterioration, and escalation to alternate therapy.

The company advised that the study’s endpoint was met, driven predominantly by a mortality rate of 1.9% in the FlowTriever arm. This represented a 90% reduction compared to the 29.5% mortality rate seen in patients treated with other therapies.

“The remarkably low mortality seen with FlowTriever demonstrates the benefit of rapidly identifying PE patients and getting them to an interventionalist for assessment,” commented Dr. Silver in the company’s press release. “It is time for our hospital systems to develop standardized care pathways for PE, similar to what has been done in other major cardiovascular diseases such as heart attack and stroke.”

Dr. Silver is an interventional cardiologist and vascular medicine specialist at OhioHealth Riverside Methodist Hospital in Columbus, Ohio.

Dr. Horowitz, who is a cardiologist and critical care physician at NYU Grossman School of Medicine in New York, New York, added, “High-risk PE persists as one of the deadliest cardiovascular diseases. Outcomes have remained unchanged for decades. The FLAME data show that FlowTriever is an important new treatment option that offers a dramatic improvement in survival.”

In April 2021, Inari Medical announced the commencement of enrollment in the FLAME study and advised that the FlowTriever system has received FDA 510(k) clearance and European CE Mark approval for the treatment of PE and clot in transit in the right atrium.