2025.5.17

Access Snapshot: Full-Scale 3D Heart Model Reimbursement

A submission by crossMedical, Inc. for reimbursement of its soft life-size 3D heart model was also reviewed this week, in addition to the two new device listing decisions summarized in our FY 2025 new listings page here. Their product is a life-size 3D model of the heart created based on multi-slice CT imaging information for patients with complex congenital heart disease that is difficult to diagnose and determine the surgical procedure for using existing imaging techniques. It received marketing approval in Japan on 27 July 2023 based on a clinical trial conducted in Japan.

They showed that for 20 patients with complex congenital heart disease, 65.0% (13/20: 95% confidence interval 40.8-84.6%) were not able to develop an appropriate preoperative plan without the additional information provided by their product. Moreover, in all cases the anatomical diagnosis of the product and the heart identified at the time of chest opening were consistent, and no structural incompatibility was observed. Furthermore, in 4 out of 20 cases (20%), the use of the product in preoperative planning enabled modification to the appropriate procedure. (From someone who still enjoys flipping through the Netter Atlas - this is pretty interesting technology!)

crossMedical submitted for Category C2 reimbursement in Japan, meaning that a new technical fee is also needed. They asked for 419,733 JPY per procedure based on the Cost Calculation Method. However, it was decided that it would only receive a new technical fee in Japan. Provisionally they will be allowed reimbursement based on "K939 Additional fee for surgical support such as imaging (2) By using full-scale three-dimensional models of organs" with a slightly lower technical fee of 180,000 JPY per procedure. They projected about 569 patients per year at peak annual sales after 2 years – although that was based on their requested reimbursement amount of 419,733 JPY per procedure.

This is an example of how the device reimbursement submission process in Japan sometimes does not lead to a reimbursement of the device itself (even if it is requested!), but it can trigger the establishment of a new technical fee. For more examples of devices that took that approach – either intentionally or not – please see our post below.

Please contact us if need support with device reimbursement for Japan!

Subscribe to receive Japan MedTech Access Forum (J-MAF) updates

We respect your privacy. You will NOT be sent relentless emails by GinePro!