Inari Medical Announces IDE Approval To Study The FlowTriever System For The Treatment Of Pulmonary Embolism
IRVINE, Calif., March 8, 2016 /PRNewswire/ -- Inari Medical, Inc. announced today that it has received an Investigational Device Exemption ("IDE") for a study to evaluate the safety and effectiveness of the FlowTriever Retrieval/Aspiration System. Ken Rosenfield, MD, Section Head for Vascular Medicine and Intervention, Massachusetts General Hospital and Victor Tapson, MD, Associate Director, Pulmonary and Critical Care Division, Cedars-Sinai Medical Center, Los Angeles are the Co-Principal Investigators of the study.
The FlowTriever Pulmonary Embolectomy Clinical Study ("FLARE") is approved to begin enrollment of patients at up to 20 sites in the U.S. and will evaluate safety and effectiveness of the FlowTriever System for use in the removal of emboli for treatment of acute pulmonary embolism.
"This study of the FlowTriever System will enhance our understanding of the patients best suited for rapid intervention," stated Dr. Rosenfield. "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," added Dr. Tapson. Study activities are already underway at more than 15 sites with patient enrollment anticipated over the coming weeks. FlowTriever is the first device designed specifically to retrieve clot from the pulmonary arteries, and it does not require the use of thrombolytics which can carry a risk of bleeding. "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," said Inari President and CEO Bill Hoffman.
About The FlowTriever Retrieval/Aspiration System
The FlowTriever Retrieval/Aspiration System ("FlowTriever System") is a catheter-based mechanical thrombectomy device for percutaneous endovascular retrieval of emboli from the peripheral vasculature and is intended for use in the proximal pulmonary arterial system. The FlowTriever System is designed to mechanically remove emboli and restore blood flow through the pulmonary arteries in patients experiencing acute PE.
About The FLARE Study
The FLARE study is a prospective, multicenter, single-arm study evaluating the FlowTriever in 150 patients with acute pulmonary embolism. The study will be conducted at up to 20 investigational sites in the U.S. More information on the FLARE study can be found at www.clinicaltrials.gov under NCT#02692586.
About Inari Medical, Inc.
Inari Medical, Inc. is dedicated to the development of innovative catheter-based technologies for the interventional treatment of vascular thrombus and emboli, focusing on large volume clot removal from large vessels. The FlowTriever System provides a new approach to thrombectomy without the need for thrombolytics. The FlowTriever is 510(k) cleared for thrombectomy in the peripheral vessels. Use for the treatment of pulmonary embolism is investigational; the device has not been cleared in the United States for this specific use. Inari Medical, founded in 2013, is a venture capital backed medical device company formed by Inceptus Medical, a medical device incubator. The company is backed by Versant Ventures, U.S. Venture Partners, the founders, and other private investors. For more information, please visit www.inarimedical.com.
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SOURCE Inari Medical, Inc.
