Inari Medical Announces First Patient Treated with the FlowTriever Infusion Aspiration System Following 510(k) Clearance
IRVINE, CALIFORNIA, March 12, 2015 – Inari Medical Inc., a venture capital backed medical device company focused on the interventional treatment of vascular thrombus and emboli, announced the treatment of the first patient with its FlowTriever Infusion Aspiration System. The FlowTriever System received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) in February to treat emboli (blood clots) in the peripheral vasculature.
“We are pleased to be the first site to perform a procedure using the FlowTriever System,” said Dr. Tod Engelhardt, MD, chairman of the Cardiovascular and Thoracic Surgery Division of East Jefferson General Hospital in Metairie, Louisiana. “The FlowTriever offered an efficient, minimally invasive treatment and rapidly restored blood flow in the occluded vessel. I believe the FlowTriever is a promising new advancement in the treatment of vessels occluded by emboli.”
“The FlowTriever System is the first offering in Inari’s planned product portfolio,” said Bill Hoffman, Inari’s chief executive officer. “This device will be available for embolus treatment in peripheral applications at select centers and we plan to add additional centers as we gain clinical experience. We are pleased to provide a new tool for interventionalists to deal with emboli and rapidly restore flow in occluded vessels.” added Mr. Hoffman.
About the FlowTriever Infusion Aspiration System
The FlowTriever System includes three separate components that work in concert. The FlowTriever catheter has a self-expanding Nitinol framework designed to engage, disrupt and remove emboli from blood vessels with minimal trauma. The Aspiration Guide Catheter is a flexible, large bore (20F) catheter that facilitates the delivery, positioning and deployment of the FlowTriever catheter as well as exceptional aspiration capability. The Retraction Aspirator provides a vacuum for aspiration during FlowTriever retraction to enhance its effectiveness in restoring blood flow. The entire system is designed for use over a standard exchange-length, 0.035″ guide wire.
About Inari Medical
Inari Medical, founded in 2013, is a venture capital backed medical device company formed by Inceptus Medical. Inari is developing a system for the interventional treatment of vascular thrombus and emboli. The company is backed by Versant Ventures, U.S. Venture Partners, the founders, and other private investors.
For more information, visit the company’s website at inarimedical.com.
Bill Hoffman, Chief Executive Officer, Inari Medical Inc.