Prospective Clinical Data on the FlowTriever System Confirms Excellent Results in the Treatment of Pulmonary Embolism
Multicenter FLARE Study for PE Treatment
IRVINE, CALIFORNIA – Inari Medical, Inc., announced today the presentation of results from its FlowTriever Pulmonary Embolectomy ("FLARE") Clinical Study that evaluated the safety and effectiveness of the FlowTriever Retrieval/Aspiration System for the treatment of pulmonary embolism ("PE"). The results were presented by Thomas Tu, MD, Interventional Cardiologist, Baptist Health, Louisville, Kentucky at the recent Scientific Sessions of the Society for Cardiovascular Angiography and Interventions ("SCAI") held in San Diego, CA.
The FLARE study is a prospective, multicenter, single-arm study evaluating the FlowTriever System in 106 patients with acute PE at 18 sites in the United States. Patients with proximal PE and right heart strain (RV/LV ratio ? 0.9) were eligible to participate. Treatment with the FlowTriever System was used to mechanically remove blood clots in the pulmonary arteries.
The mean RV/LV ratio in the study decreased from a baseline 1.53 to 1.15 at 48 hours post-procedure, a difference of 0.39 (p<0.0001). The study also demonstrated excellent safety at 30 days, with a low 3.8% rate of major adverse events and no device related complications. Median ICU stay was one day and overall median length of hospital stay was three days.
"The significant improvement in right heart function shown with the FlowTriever System compares very favorably with outcomes of other techniques used to treat PE," said Dr. Thomas Tu. "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". "The results of the FLARE study mark an exciting advancement in the treatment of acute pulmonary embolism patients," stated Victor Tapson, MD, Associate Director, Pulmonary and Critical Care Division, Cedars-Sinai Medical Center, Los Angeles and Co-Principal Investigator of the study. "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."
"The FlowTriever System represents a breakthrough in treatment options for this large patient population," added Dr. Ken Rosenfield, MD, Section Head for Vascular Medicine and Intervention, Massachusetts General Hospital and Co-Principal Investigator of the study. "These results indicate that mechanical thrombectomy with the FlowTriever System will play an increasing role in the management of pulmonary embolism."
About Inari Medical, Inc.
Inari Medical, Inc. is a privately held venture backed medical device company dedicated to the development of innovative catheter-based technologies for the treatment of venous thromboembolism ("VTE"). Inari is focused on solutions that enable the safe removal of large clot volumes from big vessels without the use of thrombolytic drugs. Inari has developed two novel mechanical thrombectomy technology platforms, the FlowTriever and ClotTriever Systems. Both Systems are 510(k) cleared by the U.S. FDA for thrombectomy in the peripheral vessels and have also received the CE mark. Inari was founded in 2013 as a spin-out of Inceptus Medical, a medical device incubator. The company is backed by Gilde Healthcare, Versant Ventures, U.S. Venture Partners, the founders and other private investors. For more information, please visit www.inarimedical.com.
About The FLARE Study
The FLARE study is a prospective, multicenter, single-arm study evaluating the FlowTriever in 106 patients with acute pulmonary embolism at 18 sites in the United States. More information on the FLARE study can be found at www.clinicaltrials.gov under NCT#02692586.
Drew Hykes, Chief Commercial Officer