FDA approves trial for Inari Medical’s clot-busting FlowTriever

Inari Medical said today that it won an investigational device exemption from the FDA for a clinical trial of its FlowTriever device, which is designed to retrieve pulmonary embolisms.

Irvine, Calif.-based Inari said it expects to begin enrollment in the 150-patient Flare trial in the coming weeks. The primary safety endpoint is major adverse events within 48 hours, defined as device-related death, major bleeding, and treatment-related events. The efficacy endpoint is reduction in right ventricle/left ventricle ration from baseline to 48 hours.

The Flare study is slated to close in November 2017, with final data collection for the primary outcome in September 2017, according to ClinicalTrials.gov.

“Flare represents the first FDA-approved trial designed to show that PE can be treated effectively by simply removing the clot through a percutaneous procedure. We remain committed to building a solid foundation of clinical evidence for the FlowTriever,” president & CEO Bill Hoffman said in prepared remarks.

“This study of the FlowTriever System will enhance our understanding of the patients best suited for rapid intervention,” added co-principal investigator Dr. Ken Rosenfield of the Mass. General Hospital.

“The initiation of the FLARE study represents an important milestone for this exciting new endovascular tool and a critical step towards improving outcomes in a patient population with few treatment options. I look forward to collaborating with a talented group of physician investigators,” said co-principal investigator Dr. Victor Tapson, of the Cedars-Sinai Medical Center in Los Angeles.

The post FDA approves trial for Inari Medical’s clot-busting FlowTriever appeared first on MassDevice.

from MassDevice http://ift.tt/1ntKIDd