Inari Medical Secures Approval and New Partner in Japan
Inari Medical, Inc. (NASDAQ: NARI) has made a significant stride in improving vascular care by gaining national reimbursement approval for its ClotTriever Thrombectomy System. This approval came from the Japanese Ministry of Health, Labor and Welfare following a regulatory nod from the Pharmaceuticals and Medical Devices Agency.
Importance of the ClotTriever System
The ClotTriever is designed to effectively treat patients suffering from deep vein thrombosis (DVT). Its unique mechanism allows for comprehensive thrombus removal, making it a vital tool in managing this condition. Japan's regulatory body has recognized this by establishing a new reimbursement category specifically for ClotTriever, reflecting its substantial clinical data supporting both safety and efficacy.
New Distribution Partnership
To expand its reach within the Japanese market, Inari has partnered with Medikit Co., Ltd., a well-established medical device manufacturer with extensive distribution capabilities across Japan and beyond. This collaboration is set to enhance the accessibility of the ClotTriever system, enabling it to reach more patients in need of advanced DVT treatment.
Advancing Clinical Expectations
With the new partnership, Inari is prepared to initiate a Post Market Surveillance study involving 100 patients. This study will help to further assess the performance and satisfaction with the ClotTriever System in clinical settings. Drew Hykes, CEO of Inari, emphasized the transformative potential of the ClotTriever's reimbursement approval, underlining how it will meet the significant clinical needs of DVT patients in Japan.
Clinical Data and Outcomes
The ClotTriever system is already recognized globally, with over 75,000 procedures performed to date. Its robust clinical performance has been highlighted in various studies, with recent reports from the 500-patient ClotTriever CLOUT Registry demonstrating a high safety profile and effective clot removal rates. The ongoing Randomized Controlled Trial, DEFIANCE, which compares ClotTriever against standard anticoagulation treatment, is expected to further bolster its profile in the medical community.
About Inari Medical, Inc.
Inari Medical stands by its mission of prioritizing patients and addressing the unmet needs within vascular care. Their commitment is not just to create innovative medical solutions but also to establish a framework for clinical education and research enhancement. This holistic approach aims at improving overall patient outcomes, targeting venous thromboembolism and related vascular diseases.
About Medikit Co., Ltd.
Medikit Co., Ltd. has a longstanding reputation since its establishment in 1973 and is noted for providing top-quality vascular medical products. The company's focus on interventional products has made it a leading entity in Japan’s healthcare space. Medikit operates with a workforce of over 1,300 employees, ensuring their impact reaches beyond Japan into international markets.
Investor Contact:
Neil Bhalodkar
IR@inarimedical.com
Frequently Asked Questions
What is the ClotTriever Thrombectomy System?
The ClotTriever Thrombectomy System is a medical device designed to safely and effectively remove blood clots from veins, particularly for patients suffering from deep vein thrombosis (DVT).
Who has partnered with Inari Medical in Japan?
Inari Medical has partnered with Medikit Co., Ltd., a leading vascular medical device manufacturer in Japan, to enhance the distribution of the ClotTriever system.
What does the new reimbursement approval mean for Inari Medical?
The national reimbursement approval reflects the recognition of ClotTriever's clinical efficacy and safety, facilitating easier access for patients in Japan.
How many procedures have been performed using the ClotTriever system?
Globally, over 75,000 procedures have been performed using the ClotTriever system, showcasing its widespread adoption and effectiveness.
What are the future goals for Inari Medical in Japan?
Inari Medical aims to expand its offerings in the Japanese market, including post-market studies to further validate the ClotTriever system and potentially introduce additional medical solutions.
