Prospective Clinical Data on the ClotTriever System Shows Excellent Results in the Treatment of Deep Vein Thrombosis
IRVINE, Calif., Nov. 6, 2019 /PRNewswire/ -- Inari Medical, Inc. today announced the presentation of early outcomes from the ClotTriever Outcomes Registry ("CLOUT") using the ClotTriever Mechanical Thrombectomy System for treatment of acute and chronic lower extremity deep vein thrombosis ("DVT"). Initial results for the first 50 patients were presented by principal investigator David J. Dexter, MD, a vascular surgeon at Sentara Healthcare in Norfolk, VA at the VIVA 2019 late-breaking clinical trials session held in Las Vegas, NV.
CLOUT is a 500-patient prospective, multicenter, single-arm registry evaluating real world patient outcomes after treatment of lower extremity DVT with ClotTriever. The study is unique in that there are no exclusions for age of clot. Three-quarters of patients had clot over two weeks old and over half failed other therapies prior to treatment. Nonetheless, thrombus was removed in all patients, and over three-quarters met the study primary effectiveness endpoint of near-complete clot resolution. No patients received thrombolytics, no bleeding complications were reported, and no procedure or device related major adverse events were reported. Average blood loss was less than 30cc.
"Early results from the first 50 patients enrolled in CLOUT are encouraging with 76% of patients free from post-thrombotic syndrome ("PTS") within 30 days of treatment," said Dr. Dexter. "We may finally have the tools to truly test the hypothesis that early resolution of venous thrombus in DVT patients may prevent PTS."
"CLOUT reflects Inari's long-term commitment to the care of venous thromboembolism ("VTE") patients, and to the production of clinical data to further the understanding and advance the treatment of this disease," said Bill Hoffman, Inari's Chief Executive Officer. "We remain committed to revolutionizing VTE treatment with devices that remove large clot volume from large vessels while completely eliminating lytics and their consequent cost, ICU stay, and bleeding complications."
About the ClotTriever Thrombectomy System
The ClotTriever System is designed to remove large clot volume from large veins. The procedure does not require use of thrombolytic drugs, which carry significant risk of bleeding and are contraindicated in many patients. The ClotTriever System is 510(k) cleared for the non-surgical removal of thrombus (blood clots) from the peripheral vasculature.
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 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 CLOUT Registry can be found at www.clinicaltrials.gov under NCT #03575364.
Eric Khairy, Marketing Director
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SOURCE Inari Medical