Inari Medical Announces First Patient Enrolled in FLASH Registry Using the FlowTriever System for Pulmonary Embolism

IRVINE, Calif., Dec. 6, 2018 /PRNewswire/ — Inari Medical, Inc. announced today the enrollment of the first patient in the FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (“FLASH”) using the FlowTriever® System for the treatment of pulmonary embolism (PE).

 

FLASH is a 500-patient prospective, multicenter registry study to evaluate real world outcomes after treatment of patients with intermediate and high-risk PE with FlowTriever. FLASH represents the latest investment in a robust pipeline of clinical studies and follows the completion of the FlowTriever Pulmonary Embolectomy (“FLARE”) clinical study early this year and the recent launch of the ClotTriever Outcomes Registry (“CLOUT”) evaluating outcomes after treatment of deep vein thrombosis (DVT) with Inari’s ClotTriever system.

“We are pleased to be the first site to enroll a patient in FLASH,” said Dr. Thomas M. Tu, Director of the Pulmonary Embolism Response Team (PERT) at Baptist Health Louisville.  “In our experience, the FlowTriever System consistently and safely removes large volumes of clot from the pulmonary arteries, allowing us to improve heart function while avoiding the need for thrombolytics drugs and their associated bleeding risk.  FlowTriever is the only mechanical thrombectomy device indicated for the treatment of PE and has become our first line therapy.”

“Compared to the previous FLARE study, FLASH will allow us to evaluate both short and long term outcomes in a much broader group of patients,” said Dr. Catalin Toma, Interventional Cardiologist, UPMC Presbyterian and Principal Investigator for FLASH. “In particular, the six-month follow-up will allow us to determine how significant clot removal improves cardiac hemodynamics, symptoms and quality of life metrics over the longer term.”

“FLASH reflects Inari’s commitment to the production of clinical data to help advance the understanding and treatment of PE and we look forward to working with a dedicated group of physician investigators to execute this important study,” said Bill Hoffman, Inari’s Chief Executive Officer.  “We are also pleased to announce the achievement of another important milestone having treated our 1,000th patient this month, a testament to our physician community’s dedication to non-lytic based treatment of venous thromboembolism [VTE] patients.”

 

About the FlowTriever Thrombectomy System
The FlowTriever System is designed to remove large clot volume from large veins, including pulmonary embolism.  The procedure does not require use of thrombolytic drugs, which carry significant risk of bleeding and are contraindicated in many patients. The FlowTriever System is 510(k) cleared for the non-surgical removal of thrombus (blood clots) from the peripheral vasculature and for the treatment of pulmonary embolism.

 

About Inari Medical, Inc.
Inari Medical, Inc. is a privately held venture backed medical device company dedicated to the development of innovative catheter-based technologies for the treatment of venous thromboembolism.  Inari is focused on solutions that enable the safe removal of large clot volumes from big vessels without the use of thrombolytic drugs.  Inari has developed two novel mechanical thrombectomy technology platforms.  The FlowTriever System is 510(k) cleared by the U.S. FDA for the treatment of pulmonary embolism.  The ClotTriever System is 510(k) cleared for thrombectomy in the peripheral vessels.  Inari was founded in 2013 as a spin-out of Inceptus Medical, a medical device incubator. The company is backed by Gilde Healthcare (www.gildehealthcare.com), Versant Ventures (www.versantventures.com), U.S. Venture Partners (www.usvp.com), the founders and other private investors.  For more information, please visit www.inarimedical.com.  More information on the FLASH Registry can be found at www.clinicaltrials.gov under NCT#03761173.

 

 

Contact
Tara Dunn, Vice President Clinical Affairs
tarad@inarimedical.com

 

###

Inari Medical Announces First Patient Enrolled in CLOUT Registry Using the ClotTriever Thrombectomy System

IRVINE, CALIFORNIA – September 27, 2018 — Inari Medical, Inc. announced today the enrollment of the first patient in the ClotTriever Outcomes Registry (“CLOUT”) using the ClotTriever® Thrombectomy System.

+ Read More

FlowTriever System from Inari Medical Receives FDA 510(k) Clearance for Treatment of Pulmonary Embolism

IRVINE, CALIFORNIA – May 21, 2018 – Inari Medical, Inc., announced today the FlowTriever System has received FDA 510(k) clearance for the treatment of pulmonary embolism (“PE”). This clearance makes the FlowTriever System the first and only thrombectomy device cleared by the FDA for the treatment of PE.

+ Read More

Prospective Clinical Data on the FlowTriever System Confirms Excellent Results in the Treatment of Pulmonary Embolism

Multicenter FLARE Study for PE Treatment

IRVINE, CALIFORNIA – April 27, 2018 – Inari Medical, Inc., announced today the presentation of results from its FlowTriever Pulmonary Embolectomy (“FLARE”) Clinical Study that evaluated the safety and effectiveness of the FlowTriever Retrieval/Aspiration System for the treatment of pulmonary embolism (“PE”). The results were presented by Thomas Tu, MD, Interventional Cardiologist, Baptist Health, Louisville, Kentucky at the recent Scientific Sessions of the Society for Cardiovascular Angiography and Interventions (“SCAI”) held in San Diego, CA.

+ Read More

Inari Medical Announces Completion of $27 Million Series C Financing

IRVINE, Calif., March 29, 2018 /PRNewswire/ — Inari Medical, Inc., announced today the close of a Series C financing totaling $27.0 million. The financing was led by new investor Gilde Healthcare and was joined by all of Inari’s existing investors including Versant Ventures and U.S. Venture Partners. Geoff Pardo of Gilde Healthcare will join Inari’s Board of Directors.

+ Read More

Inari Medical Announces Completion of Patient Enrollment in the FLARE Study for the Treatment of Pulmonary Embolism

IRVINE, CALIFORNIA – October 19, 2017 – Inari Medical, Inc., a privately held venture backed medical device company dedicated to the development of innovative catheter-based technologies for the treatment of venous thromboembolism (“VTE”), announced today it has completed enrollment of its Investigational Device Exemption (“IDE”) study. The FlowTriever Pulmonary Embolectomy Clinical Study (“FLARE”) study is designed to evaluate the safety and effectiveness of the FlowTriever Retrieval/Aspiration System for the treatment of pulmonary embolism.

+ Read More

Inari Medical Announces First Patient Treated with the ClotTriever™ Thrombectomy System; FDA 510(k) Clearance Received for Peripheral Thrombectomy

IRVINE, CALIFORNIA – April 10, 2017 – Inari Medical Inc., a venture capital backed medical device company focused on the interventional treatment of venous thrombus, announced the treatment of the first patient with its ClotTriever Thrombectomy System. The ClotTriever Thrombectomy System received 510(k) marketing clearance from the U.S. Food and Drug Administration on February 16 for the non-surgical removal of thrombus (blood clots) from the peripheral vasculature.

+ Read More

Inari Medical Announces IDE Approval To Study The Flowtriever System For The Treatment Of Pulmonary Embolism

IRVINE, CALIFORNIA – March 8, 2016 – 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.

+ Read More

Inari Medical And Inceptus Medical Announce Receipt Of TCT Innovation Award

IRVINE, CALIFORNIA, November 23, 2015 – Inari Medical, Inc. and Inceptus Medical LLC announced today that the Inari FlowTriever® Retrieval /Aspiration System for thrombectomy received a 1st place Innovation Award at the 2015 Transcatheter Therapeutics (TCT) conference in San Francisco.

“We are pleased to have the FlowTriever thrombectomy system showcased at such a large and prestigious venue as TCT,” says Bill Hoffman, President and CEO of Inari. Bob Rosenbluth, President of Inceptus added, “We are proud to have Inari get this recognition at the largest medical device conference for interventional therapy. This is a nice honor as we initiate our pivotal trial to investigate the use of the FlowTriever specifically for the treatment of pulmonary embolism.”

+ Read More

Inari Medical Announces Closing of $12.4 Million Venture Financing

IRVINE, CALIFORNIA, June 30, 2015 – Inari Medical, Inc. announced today that it has closed a $12.4 million Series B venture capital financing. The financing was led by members of the board of directors and returning investors Versant Ventures and US Venture Partners. The round also included participation by several medical device industry veterans.

“We are very pleased to complete this financing with the support of new and existing investors,” said Bill Hoffman, who joined in February 2015 as President and Chief Executive Officer. “These funds will allow us to significantly enhance company value with continued product improvements and clinical studies that demonstrate the value of the FlowTriever™ Retrieval/Aspiration System in several markets with important unmet needs.” The FlowTriever is an FDA cleared, catheter-based thrombectomy device shown to extract significant amounts of clot from large vessels. “Inari’s approach to emboli retrieval is novel. It provides the interventionalist with a tool that can substantially reduce the need for thrombolytics, which carry unacceptably high risk for many patients,” added Bob Rosenbluth, Chairman and Co-founder.

+ Read More

1 2