March 10, 2023 — Inari Medical, Inc., a medical device company with a mission to treat and transform the lives of patients suffering from venous and other diseases, announced positive results from the FLAME study in high-risk/massive pulmonary embolism (“PE”). The data was presented during the Late-Breaking Clinical and Investigative Horizons session at the 2023 ACC (American College of Cardiology) conference on March 5th by national Principal Investigator (PI) Mitchell Silver, DO, FACC, FVSM, RPVI, an interventional cardiologist and vascular medicine specialist at OhioHealth Riverside Methodist Hospital.
FLAME is the largest prospective study of interventional treatment in high-risk PE, a patient population with a historical mortality rate of 25-50%. The study collected data on patients treated with FlowTriever and on those treated with other therapies in a context arm. The study was stopped early due to overwhelmingly positive outcomes in the FlowTriever patients.
The primary endpoint measured a composite of meaningful in-hospital clinical outcomes, including mortality, major bleeding, clinical deterioration, and escalation to an alternate therapy. The endpoint was met in the FlowTriever arm, driven predominantly by a low mortality rate of 1.9%. This represented a 90% reduction compared to the 29.5% mortality rate seen in patients treated with other therapies in the context arm.
"High-risk PE persists as one of the deadliest cardiovascular diseases,” said Dr. James Horowitz, a cardiologist and critical care physician at NYU Grossman School of Medicine and FLAME national PI. “Outcomes have remained unchanged for decades. The FLAME data shows that FlowTriever is an important new treatment option that offers a dramatic improvement in survival.”
“The remarkably low mortality seen with FlowTriever demonstrates the benefit of rapidly identifying PE patients and getting them to an interventionalist for assessment,” said Dr. Silver. “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.”
“FLAME is yet another example of Inari’s commitment to developing impactful, high-quality clinical evidence in VTE,” said Thomas Tu, MD, Chief Medical Officer of Inari Medical. “The results of the trial will have an immediate impact on the treatment of high-risk PE patients and will ultimately change clinical practice guidelines for that population. Furthermore, the magnitude of the benefit seen in FLAME will undoubtably influence treatment decisions over a broader spectrum of PE patients.”
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