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The US Food and Drug Administration (FDA) has granted 510(k) clearance to the FlowTriever System for the treatment of pulmonary embolism (PE).
This makes the FlowTriever System the first and only thrombectomy device cleared by the FDA for the treatment of PE.
The 510(k) clearance was based on results from the FlowTriever Pulmonary Embolectomy (FLARE) study.
In this prospective, single-arm study, researchers evaluated the FlowTriever System in 106 patients with acute PE. 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 decreased from a baseline of 1.53 to 1.15 at 48 hours post-procedure, a difference of 0.39 (P<0.0001).
At 30 days, the rate of major adverse events was 3.8%. There were no device-related complications.
Patients had a median hospital stay of 3 days and a median stay in the intensive care unit of 1 day.
“The FlowTriever System is an exciting advancement in the treatment of acute pulmonary embolism patients,” said FLARE investigator Wissam Jaber, MD, of Emory University Hospital in Atlanta, Georgia.
“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 FlowTriever System is a product of Inari Medical, Inc.
The US Food and Drug Administration (FDA) has granted 510(k) clearance to the FlowTriever System for the treatment of pulmonary embolism (PE).
This makes the FlowTriever System the first and only thrombectomy device cleared by the FDA for the treatment of PE.
The 510(k) clearance was based on results from the FlowTriever Pulmonary Embolectomy (FLARE) study.
In this prospective, single-arm study, researchers evaluated the FlowTriever System in 106 patients with acute PE. 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 decreased from a baseline of 1.53 to 1.15 at 48 hours post-procedure, a difference of 0.39 (P<0.0001).
At 30 days, the rate of major adverse events was 3.8%. There were no device-related complications.
Patients had a median hospital stay of 3 days and a median stay in the intensive care unit of 1 day.
“The FlowTriever System is an exciting advancement in the treatment of acute pulmonary embolism patients,” said FLARE investigator Wissam Jaber, MD, of Emory University Hospital in Atlanta, Georgia.
“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 FlowTriever System is a product of Inari Medical, Inc.
The US Food and Drug Administration (FDA) has granted 510(k) clearance to the FlowTriever System for the treatment of pulmonary embolism (PE).
This makes the FlowTriever System the first and only thrombectomy device cleared by the FDA for the treatment of PE.
The 510(k) clearance was based on results from the FlowTriever Pulmonary Embolectomy (FLARE) study.
In this prospective, single-arm study, researchers evaluated the FlowTriever System in 106 patients with acute PE. 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 decreased from a baseline of 1.53 to 1.15 at 48 hours post-procedure, a difference of 0.39 (P<0.0001).
At 30 days, the rate of major adverse events was 3.8%. There were no device-related complications.
Patients had a median hospital stay of 3 days and a median stay in the intensive care unit of 1 day.
“The FlowTriever System is an exciting advancement in the treatment of acute pulmonary embolism patients,” said FLARE investigator Wissam Jaber, MD, of Emory University Hospital in Atlanta, Georgia.
“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 FlowTriever System is a product of Inari Medical, Inc.