Inari Medical said today it won FDA 510(k) clearance for its FlowTriever stent retriever designed to treat pulmonary embolisms.
The clearance came based upon results from the company’s Flare clinical study of the device, which examined data from 106 patients with acute pulmonary embolisms treated with the FlowTriever at 18 US sites, the Irvine, Calif.-based company said.
Results from the study indicated a decrease in mean RV/LV ratio from baseline of 1.53 to 1.15 at 48 hours post-procedure. Data also indicated excellent safety at 30 days with a 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. 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,” Flare clinical study investigator Dr. Wissam Jaber of Emory University Hospital said in a prepared statement.
“The Flare data and resulting PE-specific clearance reflects the diligent work of a talented group of physician investigators. 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,” CEO Bill Hoffman said in a press release.
Last month, Inari Medical 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.