FLAME Study Demonstrates 90% Survival Improvement in High-Risk Pulmonary Embolism with Inari Medical FlowTriever System

Rhea-AI Summary

Inari Medical, Inc. (NASDAQ: NARI) announced positive results from the FLAME study for high-risk pulmonary embolism (PE) during the 2023 ACC conference. This is the largest prospective study of interventional treatment in this patient group, historically facing a 25-50% mortality rate. The study showed a mortality rate of just 1.9% in patients treated with FlowTriever, a 90% reduction compared to the 29.5% rate in the control group. The trial's early termination highlights the significant effectiveness of FlowTriever, suggesting it may change clinical practice guidelines and improve survival rates for high-risk PE patients.

Positive

• FLAME study showed a mortality rate of 1.9% with FlowTriever, significantly lower than the 29.5% in control.
• The study was stopped early due to overwhelmingly positive outcomes.
• Results will likely influence treatment decisions across a broader spectrum of PE patients.

Negative

• None.

IRVINE, Calif., March 06, 2023 (GLOBE NEWSWIRE) -- Inari Medical, Inc. (NASDAQ: NARI) (“Inari”) 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.”

About Inari Medical, Inc.

Patients first. No small plans. Take care of each other. These are the guiding principles that form the ethos of Inari Medical. We are committed to improving lives in extraordinary ways by creating innovative solutions for both unmet and underrecognized health needs. In addition to our purpose-built products, we leverage our capabilities in education, clinical research, and program development to improve patient outcomes. We are passionate about our mission to establish our treatments as the standard of care for venous thromboembolism and beyond. We are just getting started.

Investor Contact:

ICR Westwicke Caroline Corner

Phone +1-415-202-5678

caroline.corner@westwicke.com

FAQ

What are the results of the FLAME study for Inari Medical's FlowTriever?

The FLAME study showed a mortality rate of 1.9% in patients treated with FlowTriever, compared to 29.5% in the control group.

When were the FLAME study results presented?

The results were presented on March 5, 2023, at the American College of Cardiology conference.

What is the significance of the FLAME study for pulmonary embolism treatment?

The study indicates that FlowTriever may significantly improve survival rates in high-risk pulmonary embolism patients.

How might the FLAME study impact clinical practice guidelines?

The results are expected to change clinical practice guidelines for treating high-risk pulmonary embolism patients.

What was the sample size of the FLAME study?

FLAME is noted as the largest prospective study focused on interventional treatment in high-risk pulmonary embolism.