FlowTriever system receives FDA 510(k) clearance
Inari Medical, Inc. has announced the FlowTriever System has received FDA 510(k) clearance for the treatment of pulmonary embolism (“PE”). This clearance makes the FlowTriever System the first and only thrombectomy device cleared by the FDA for the treatment of PE. The PE-specific clearance was based upon the strength of the recently released results from the FlowTriever Pulmonary Embolectomy (“FLARE”) Clinical Study.
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 non-surgically remove blood clots in the pulmonary arteries without the need for thrombolytic drugs.
The mean RV/LV ratio in the study decreased from a baseline of 1.53 to 1.15 at 48 hours postprocedure, 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.
“The FlowTriever System is an exciting advancement in the treatment of acute pulmonary embolism patients,” stated Wissam Jaber, MD, Emory University Hospital and FLARE Clinical Study Investigator.
“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.”
“The FLARE data and resulting PE-specific clearance reflects the diligent work of a talented group of physician investigators,” said Inari Medical CEO Bill Hoffman.
“This marks another major milestone for Inari towards our goal of transforming the treatment of venous thromboembolism by developing solutions for removing large clot volume from big vessels without the use of thrombolytic drugs.” About Inari Medical, Inc.