Inari Medical, Inc. (NASDAQ: NARI) (“Inari”), a medical device company with a mission to treat and transform the lives of patients suffering from venous and other vascular diseases, announced  that on December 1, 2024, it received national reimbursement approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for its ClotTriever Thrombectomy System for DVT. This announcement follows the regulatory approval of the ClotTriever system by the Pharmaceuticals and Medical Devices Agency (PMDA) in December 2023.

Due to ClotTriever’s unique mechanism of action for complete, wall-to-wall thrombus removal in patients suffering from DVT, MHLW created a new functional category that is separate from other catheter-based therapies. This new functional category comes with a reimbursement premium based upon ClotTriever’s wealth of clinical data showing safety and efficacy in removing various types of thrombi.

To facilitate commercialization of the ClotTriever system in Japan, Inari has entered into a distribution agreement with Medikit Co., Ltd., a market leading vascular medical device manufacturer serving Japan, the U.S. and over 30 other countries. With this new partnership, Inari plans to accelerate initiation of its 100-patient Post Market Surveillance study, followed by broader commercial expansion.

“MHLW’s approval of reimbursement for ClotTriever under a newly designated functional category marks a transformative milestone for Inari in Japan,” said Drew Hykes, Chief Executive Officer of Inari. “This decision underscores the value of ClotTriever in addressing unmet clinical needs, and we are thrilled to collaborate with Medikit to bring this innovative solution to Japanese DVT patients, improving lives and advancing care in the near future. Over time, we look forward to bringing our broader portfolio of purpose-built tools to the Japanese market.”

The ClotTriever system is 510(k)-cleared by U.S. FDA and CE-Marked for treatment of DVT. More than 75,000 procedures have been conducted with ClotTriever globally. Recently, two-year outcomes were reported from the 500-patient ClotTriever CLOUT Registry showing a strong safety profile, significant clot removal, and low rates of post-thrombotic syndrome.^1,2,3 ClotTriever is the most studied thrombectomy device for DVT, including the ongoing Randomized Controlled Trial, DEFIANCE, comparing ClotTriever to anticoagulation alone for patients with DVT.⁴