Inari Medical today presented results from a study of its FlowTriever retrieval and aspiration system designed to treat pulmonary embolism, touting the safety and efficacy of the system.
Results were presented by Dr. Thomas Tu of Louisville, Ky.’s Baptist Health in San Diego at the Scientific Sessions of the Society for Cardiovascular Angiography and Interventions, Irvine, Calif.-based Inari Medical said.
“The significant improvement in right heart function shown with the FlowTriever system compares very favorably with outcomes of other techniques used to treat PE. At the same time, the impressive safety profile reflects the advantages of FlowTriever’s purely mechanical approach which avoids the use of thrombolytic drugs and resulting risk of bleeding complications,” Dr. Tu said in a prepared statement.
The study enrolled a total of 106 patients with acute pulmonary embolism at 18 US sites, with the FlowTriever system used to mechanically remove blood clots in the pulmonary arteries.
Results indicated that the mean RV/LV ratio decreased from a baseline of 1.53 to 1.15 at 48 hours post-procedure, Inari said, while also demonstrating “excellent safety” at 30 days with a 3.8% rate of major adverse events and no device related complications. Median ICU stay was a single day with an overall median hospital stay of three days.
“The FlowTriever system represents a breakthrough in treatment options for this large patient population. These results indicate that mechanical thrombectomy with the FlowTriever System will play an increasing role in the management of pulmonary embolism,” co-princpal investigator Dr. Ken Rosenfield of the Massachusetts General Hospital said in a prepared release.
“The results of the Flare study mark an exciting advancement in the treatment of acute pulmonary embolism patients. Until now, there has not been an approach to rapidly restore flow to reverse right heart strain without the use of thrombolytic drugs and their inherent risk of bleeding complications,” co-principal investigator Dr. Victor Tapson of Los Angeles’ Cedars-Sinai Medical Center said in a press release.
Last month, Inari Medical said it closed a $27 million Series C round of financing, with funds slated to support commercialization of its FlowTriever and ClotTriever catheters designed for the treatment of venous thromboembolisms.
