Inari Medical’s ClotTriever System Gains Reimbursement Approval

Inari Medical Inc., a market leader in the development of medical devices for venous and vascular diseases, has recently accomplished a significant milestone in Japan. Inari's ClotTriever Thrombectomy System, which is intended to address deep vein thrombosis (DVT), received national reimbursement approval from the Ministry of Health, Labour and Welfare of Japan (MHLW) on December 01, 2024.

This approval is a significant step forward in the provision of a safe and highly effective thrombus removal solution to Japanese DVT patients, following regulatory clearance from the Pharmaceuticals and Medical Devices Agency (PMDA) in December 2023.

A New Functional Category for ClotTriever

Ministry of Health, Labour and Welfare of Japan (MHLW) has established a new functional reimbursement category that is distinct from other catheter-based therapies due to the innovative, wall-to-wall thrombus removal mechanism of the ClotTriever system. This distinction is indicative of the device's proven safety and efficacy, which are substantiated by a wealth of clinical data.

Strategic Collaboration with Medikit Co., Ltd.

To drive commercialization in Japan, Inari has partnered with MEDIKIT CORPORATION a leading vascular medical device manufacturer with a global presence. This collaboration will facilitate the launch of a 100-patient Post Market Surveillance study and support broader market expansion in Japan.

Clinical Data Highlights

• Extensive Use: Over 75,000 procedures conducted globally with ClotTriever.
• CLOUT Registry Results: Two-year data from a 500-patient study revealed a strong safety profile, significant thrombus removal, and low rates of post-thrombotic syndrome.
• Ongoing Research: The DEFIANCE Randomized Controlled Trial is comparing ClotTriever to anticoagulation alone for DVT treatment.