Inari Medical announced that it has enrolled its first patient at high risk of pulmonary embolism in a study evaluating its FlowTriever catheter as a treatment for acute massive pulmonary embolism.

The multicenter study is assessing Inari’s catheter in 250 patients at high risk of pulmonary embolism. It is the largest study ever conducted for high-risk pulmonary embolism, the Irvine, Calif. company said. The device is an over-the-wire system designed to provide treatment in a single session and eliminate the need for thrombolytic drug therapy.

Inari’s FlowTriever system has received both FDA 510(k) clearance and CE mark certification for treating pulmonary embolisms and clots in transit in the heart’s right atrium.