Inari Medical Begins FLAME Study of FlowTriever in Patients With Acute Massive PE

April 5, 2021—Inari Medical, Inc. announced the enrollment of the first high-risk pulmonary embolism (PE) patient in the FLAME study of the company’s FlowTriever for acute massive PE. The FlowTriever system has FDA 510(k) clearance and European CE Mark approval for the treatment of PE and clot in transit in the right atrium.

According to the company, FLAME is a prospective, multicenter, parallel group observational study evaluating treatment outcomes for up to 250 high-risk PE patients. The study, which is informed by evidence development guidance from the American Heart Association, aims to change the high-risk PE treatment guidelines. One in 20 PE diagnoses is categorized as high-risk and these are associated with a mortality rate of up to 40% at 90 days, advised Inari Medical.

Coprincipal Investigators Sameer J. Khandhar, MD, and Jay S. Giri, MD, enrolled the first patient in the FLAME study at the Penn Presbyterian Hospital and Hospital of the University of Pennsylvania (HUP) in Philadelphia, Pennsylvania. Dr. Khandhar is an interventional cardiologist and Clinical Assistant Professor of Medicine at Penn Medicine. Dr. Giri, an interventional cardiologist, is Director of Peripheral Intervention in the Cardiovascular Division at HUP.

“We are pleased to be the first site to enroll a patient in FLAME,” commented Dr. Khandhar in the Inari press release. “We frequently see on-table normalization of hemodynamics using FlowTriever to extract large clots in PE patients. We are eager to formally study this effect in high-risk PE patients in whom the immediacy of this impact might reverse the death spiral and save live.”

Dr. Giri added, “Conservatively managed high-risk PE is associated with high mortality, but there is limited data supporting interventional treatment. We have designed FLAME to prospectively examine all patients at participating centers with high-risk PE, including those not treated with FlowTriever, to maximize generalizability of the study.”

The company stated that it continues to invest heavily in its robust clinical study pipeline. Positive long-term late-breaking results from both the CLOUT and FLASH studies were presented at the American Venous Forum annual meeting held March 17-20. Furthermore, FLASH is being doubled in size to 1,000 patients to collect data from a conservatively managed subgroup and include sites outside the United States. In addition, 200 patients will be monitored and studied using the Apple Watch, noted Inari Medical.