Inari’s ClotTriever Thrombectomy System Gains Reimbursement Approval in Japan

December 2, 2024—Inari Medical, Inc. announced that it has received national reimbursement approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for the company’s ClotTriever thrombectomy system for treatment of deep vein thrombosis (DVT).

Additionally, the company advised that it entered into a distribution agreement with Medikit Co., Ltd. to facilitate the commercialization of the ClotTriever system in Japan.

With this new partnership, Inari plans to accelerate initiation of its 100-patient postmarket surveillance study, which will precede broader commercial expansion. The ClotTriever system was approved by Japan’s Pharmaceuticals and Medical Devices Agency in December 2023.

According to Inari, Japan’s MHLW created a new functional category for ClotTriever that is separate from other catheter-based therapies because of the device’s mechanism of action for complete, wall-to-wall thrombus removal in patients with DVT. This new functional category comes with a reimbursement premium based upon ClotTriever’s clinical data that demonstrate its safety and efficacy in removing various types of thrombi, noted the company.

The ClotTriever system has received FDA 510(k) clearance in the United States and CE Mark approval in Europe for treatment of DVT, advised Inari Medical.