FDA clears pulmonary embolism thrombectomy device
The FlowTriever System has become the first thrombectomy device designed to treat pulmonary embolism (PE) to be cleared by the FDA, Inari Medical announced in a May 21 press release.
The clearance was granted based on the results of the FLARE clinical study, which showed 106 patients who were treated with the system saw an average drop in their right ventricular to left ventricular (RV/LV) ratios from 1.53 at baseline to 1.15 two days after clot removal. FlowTriever, which works without the use of thrombolytics, was associated with a 3.8 percent rate of major adverse events in the study.
“The FlowTriever System is an exciting advancement in the treatment of acute pulmonary embolism patients,” Wissam Jaber, MD, a FLARE study investigator from Emory University Hospital, said in the release. “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.”
Inari Medical has also received FDA 510(k) clearance for its ClotTriever System, which is used for thrombectomy in the peripheral vessels.
Daniel joined TriMed’s Chicago editorial team in 2017 as a Cardiovascular Business writer. He previously worked as a writer for daily newspapers in North Dakota and Indiana.