Inari Medical Announces Interim Two-Year Results from the ClotTriever CLOUT Registry
Inari Medical, Inc. (NASDAQ: NARI) announces positive two-year interim results from the CLOUT registry, showcasing excellent safety, effectiveness, and long-term outcomes of the ClotTriever system in treating deep vein thrombosis patients. The data presented at the American Venous Forum meeting reveals significantly lower rates of Post Thrombotic Syndrome compared to historical trials, emphasizing the sustained benefits of the treatment.
The interim results from Inari Medical's CLOUT registry represent a significant milestone in the treatment of deep vein thrombosis (DVT). The reported post-thrombotic syndrome (PTS) rates at two years are substantially lower than those observed in previous studies like ATTRACT and CAVA. This data suggests that the ClotTriever system could potentially redefine the standard of care for DVT patients.
From a research perspective, the robustness of the dataset, with third-party adjudication of safety events, adds credibility to the findings. The sustained improvement in PTS rates over two years indicates that the ClotTriever system may offer long-term benefits for patients, which is crucial given the chronic nature of PTS. The ongoing DEFIANCE trial, which compares ClotTriever treatment to anticoagulation alone, will further clarify the device's efficacy.
The economic implications of the ClotTriever system's effectiveness are noteworthy. By significantly reducing the incidence of moderate-severe PTS, it could lead to a decrease in the long-term healthcare costs associated with managing chronic DVT complications. This reduction in PTS rates could translate into fewer hospitalizations, less need for additional treatments and improved quality of life for patients.
Moreover, if the ClotTriever system is established as the standard of care, Inari Medical might see an increase in demand for its product. This could potentially impact Inari's market share and financial performance positively, subject to the outcomes of the DEFIANCE trial and adoption rates by healthcare providers.
In the context of the medical device industry, the ClotTriever system's reported efficacy could influence market dynamics. Given the device's utilization and study data, Inari Medical may solidify its position as a leader in thrombectomy devices for DVT. The company's commitment to clinical research, as evidenced by the ongoing DEFIANCE trial, could further differentiate it from competitors.
Investors and stakeholders should monitor the adoption rates of the ClotTriever system and the outcomes of the DEFIANCE trial. Success in these areas may lead to an increase in Inari's stock value and could attract partnership opportunities or even acquisition interest from larger medical device companies seeking to enhance their vascular product portfolios.
03/12/2024 - 04:05 PM
Rates of Post Thrombotic Syndrome at two years were excellent and significantly lower than rates reported in historical Deep Vein Thrombosis trials
IRVINE, Calif., March 12, 2024 (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 two-year interim results from the CLOUT registry. The data was presented at the American Venous Forum meeting by principal investigator, David Dexter, MD, FACS, a vascular surgeon at Sentara Vascular Specialists in Norfolk, Virginia.
The interim results are the largest prospective, multi-center two-year dataset in deep vein thrombosis (DVT) since the ATTRACT trial and confirm the excellent safety, effectiveness, and long-term outcomes of the ClotTriever system in real-world DVT patients. Patients had low incidence of independently adjudicated safety events related to rethrombosis, with only 5.0% and 8.4% at 30-days and 6 months, respectively. In the interim analysis, 228 patients completed their two-year follow-up visit. Patients had significant and sustained improvement in post-thrombotic syndrome (PTS) over the follow-up period, with only 7.3% moderate-severe PTS at two years. The PTS rates reported in CLOUT are significantly lower than those from historical DVT studies such as ATTRACT and CAVA, which reported moderate-severe PTS rates ranging from 18-24% .
“With third-party adjudication of all safety events in this robust, large dataset, ClotTriever has a strong safety profile. And the longer-term results are suggestive of sustained benefit through a critical window when longer-term sequalae typically manifest in DVT patients,” said Dr. Dexter. “The low PTS rate that continues to improve over time is a testament to the safety and effectiveness of wall-to-wall thrombus removal with ClotTriever.”
“This data continues to reinforce the strong safety and effectiveness profile of the ClotTriever system, which is not only the most utilized, but also the most studied thrombectomy device in DVT,” said Dr. Thomas Tu, Inari’s Chief Medical Officer. “We are committed to generating best-in-class clinical data. This includes our currently enrolling randomized controlled trial, DEFIANCE, which will compare outcomes after ClotTriever treatment vs. anticoagulation alone. No other company is pursuing this level of research in VTE. In the treatment of DVT, clinical data does matter. We remain committed to establishing the ClotTriever and FlowTriever systems as standard of care for deep vein thrombosis and pulmonary embolism (PE) patients.”
PTS Rates in Context:
ClotTriever CLOUT Registry ATTRACT Anticoagulation Arm (n=236) ATTRACT Intervention Arm (n=258) CAVA Anticoagulation Arm (n=58) CAVA Intervention Arm (n=62) 2-Year PTS 19.9% 36.0% 30.6% 44.8% *30.6% *2-Year Moderate-Severe PTS 7.3% 24.0% 18.2% 24.1% *22.6% *
*Median follow-up 39.0 months
About Inari Medical, Inc.
Patients first. No small plans. Take care of each other. These are the guiding principles that form the ethos of Inari Medical. We are committed to improving lives in extraordinary ways by creating innovative solutions for both unmet and underserved health needs. In addition to our purpose-built products, we leverage our capabilities in education, clinical research, and program development to improve patient outcomes. We are passionate about our mission to establish our treatments as the standard of care for venous thromboembolism and beyond. We are just getting started.
References:
ATTRACT: Vedantham, et al. N Eng J Med . 2017. CAVA: Notten, et al. J Am Heart Assoc. 2021
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What are the two-year interim results from the CLOUT registry presented by Inari Medical, Inc. (NARI)?
The two-year interim results from the CLOUT registry presented by Inari Medical, Inc. (NARI) demonstrate excellent safety, effectiveness, and long-term outcomes of the ClotTriever system in treating deep vein thrombosis patients.
Who presented the data at the American Venous Forum meeting regarding the CLOUT registry?
The data from the CLOUT registry was presented at the American Venous Forum meeting by principal investigator, David Dexter, MD, FACS.
What were the PTS rates reported in the CLOUT registry compared to historical DVT studies?
The PTS rates reported in the CLOUT registry were significantly lower than those from historical DVT studies such as ATTRACT and CAVA, showcasing a notable improvement in patient outcomes.
What is the significance of the low PTS rate reported in the CLOUT registry?
The low PTS rate reported in the CLOUT registry indicates the safety and effectiveness of wall-to-wall thrombus removal with the ClotTriever system, leading to sustained benefits for patients.
What trial is currently enrolling to compare outcomes after ClotTriever treatment vs. anticoagulation alone?
The currently enrolling randomized controlled trial, DEFIANCE, aims to compare outcomes after ClotTriever treatment vs. anticoagulation alone, showcasing Inari's commitment to generating best-in-class clinical data.
