Inari Medical Announces In-hospital and 30-day Outcomes from the Fully Enrolled CLOUT Registry and Results from Propensity-Score Matched Comparison of CLOUT vs. ATTRACT
IRVINE, Calif., Oct. 31, 2022 (GLOBE NEWSWIRE) -- Inari Medical, Inc. (NASDAQ: NARI) (“Inari”) a medical device company focused on developing products to treat and transform the lives of patients suffering from venous and other diseases, announced positive in-hospital and 30-day outcomes from the fully-enrolled 500-patient CLOUT registry. The company also reported positive results from a propensity-matched comparison of patients treated in the CLOUT registry versus patients treated with pharmacomechanical thrombolysis in ATTRACT, an NIH-sponsored randomized controlled trial. Both data sets were presented during a late breaking clinical trial session at the VEINS conference in Las Vegas, NV.
In the first late breaking clinical trial, principal investigator, David Dexter, MD, FACS, a vascular surgeon at Sentara Vascular Specialists in Norfolk, Virginia, presented the CLOUT data set. The results confirm the excellent safety and effectiveness of the ClotTriever system in real-world DVT patients. Over 90% met the primary endpoint of complete or near-complete thrombus extraction and there was only one device-related serious adverse event. There were no reports of valve damage, vessel damage, or acute kidney injury (AKI). Rethrombosis rates were just 6.8%. These results are even more impressive given that two thirds of these patients would have been excluded from previously reported studies due to their advanced clot chronicity. Over 99% of patients were treated in a single session and avoided the use of thrombolytics.
“With 500 patients across 43 centers, CLOUT is the largest prospective data set ever reported evaluating interventional treatment of DVT,” said Dr. Dexter. “With ClotTriever, we’re now able to completely open the vein, regardless of clot age, and do so safely. Most importantly, patient outcomes were exceptional and durable. These results are exciting for patients and for physicians.”
In the second late breaker, Steven Abramowitz, MD, a vascular surgeon at MedStar Health in Washington, DC., presented results from the propensity-score matched analysis. The analysis showed that patients treated with the ClotTriever system had complete thrombus clearance at nearly twice the rate of patients in the intervention arm of ATTRACT, who were predominantly treated with the AngioJet device and catheter-directed thrombolytics. ClotTriever also resulted in significantly fewer patients with post-thrombotic syndrome (PTS), with an absolute reduction of 13% at 30 days.
"Preventing PTS is the goal of DVT treatment," said Dr. Abramowitz. "This propensity analysis compares contemporary results using ClotTriever to previously reported data and shows that ClotTriever removed more clot than other interventional options and resulted in better patient outcomes and lower PTS rates.”
“We remain committed to producing the highest quality and quantity of data in the VTE space. We believe this is our basic responsibility,” said Dr. Thomas Tu, Inari’s Chief Medical Officer. “Physicians should know on whom to use our devices and what outcomes to expect. We are going to establish ClotTriever and FlowTriever as standard of care for DVT and PE patients.”
About Inari Medical, Inc.
Inari Medical, Inc. is a medical device company with a mission to treat and transform the lives of patients suffering from venous and other diseases. Our current product offering consists of two minimally invasive, novel catheter-based mechanical thrombectomy devices that are designed to remove large clots from large vessels and eliminate the need for thrombolytic drugs. The company purpose-built its products for the specific characteristics of the venous system and the treatment of the two distinct manifestations of venous thromboembolism, or VTE: deep vein thrombosis and pulmonary embolism. The ClotTriever system is 510(k)-cleared by FDA and CE marked for the non-surgical removal of clot from peripheral blood vessels, including for the use in the treatment of deep vein thrombosis.
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