1. Office of Medical Devices II,
Points To Consider in the Review of Endovascular Treatment Devices: Japanese Regulatory View
Shin Iwamoto, Ph.D.
Office of Medical Devices II,
PMDA, Japan
HBD WG1 secretariat

2. Shin Iwamoto, PhD 
I have no relevant financial relationships

3. PMDA’s Mission
To provide safer and more effective pharmaceuticals and medical devices as fast as we can
Risk
Benefit

4. Development Support from PMDA
R&D
Non-clinical study
Clinical study
Application
Market
Consultation
Next-generation Evaluation Indicator and the Science Board
Streamlining of Process : SAKIGAKE

5. Global Clinical Trial Through HBD Activity
Conducted US-Japan joint clinical trials for two DESs
- ENDEAVOR（Medtronic Japan Co., Ltd.） - XIENCE V（Guidant Japan K.K.（then））
Place of discussion needed on the issues associated with conducting the joint clinical trial with single protocol
→ HBD WG1 has inherited duties Global clinical trials for Coronary DESs and peripheral stents have been conducted.
Paved the way for the global clinical trials 　　　　　　　　　　
Proved By Doing that conducting global clinical trials is possible.
→ Global clinical trial is now common for MDs.
Global clinical trials

6. Steps Taken in CLI-experts’ Activity
・Conduct global clinical trial using the one protocol in the US and Japan in the future
Identify mutually agreeable points
Propose the outline of the clinical trial, taking into account the differences between Japan and the US
Survey on current situations in Japan and the US
Identify and clarify differences
Understand what are already practiced in each country 6
Based on shared perspectives, the goal is to have CLI studies using one protocol in the US and Japan from now on 6

7. Lessons learned from the CLI-Sub WG activity
1.Providing the basic concept of global clinical trial during device development
- We could propose the concept of evaluation method while the device is still
under development for treatment of CLI
- Concepts could be proposed after understanding the differences in 　
　medical environment between the US and Japan.
2. Mutual understanding among US and Japan academia and
regulators has been promoted
Academia
Expectation for promoting the discussion
about DCB treatment efficiently using the framework of CLI
Regulatory
Industry

8. Current Situation of CLI patients in Japan
CLI patients have severe calcified lesions with greater disease
- Over 50% of CLI patients in Japan are on dialysis - The majority of CLI patients have comorbid conditions of diabetes mellitus - There are more Rutherford Class 5 patients than Class 4
Iida O. et al, CCI 2013;6: Approved DCBs devices for peripheral lesion are not available
10-20%
Hemodialysis
> 50%
Class 4 > 5
Rutherford
Class 5 > 4

9. Points to Consider in the review of DCBs Treatment for peripheral lesion
Concept：Reduction of restenosis with anti-restenotic drug
Effectiveness：Superior treatment outcome (vessel patency or freedom from TLR) compared with POBA
Safety: Drug-related adverse events (distal emboli)
Endovascular today 2014 December Supplement

10. For Appropriate Evaluation
The Development of New Indication for DCB
Bleow the knee
Arteriovenous fistulas (AVFs) for dialysis, etc.
Regulatory
Academia
Industry
HBD
Sharing information and constructive discussions among the stakeholders can lead to mutual understanding and solving problems
Contribution to the development of peripheral vascular devices

11. Thank you for your kind attention!
Shin Iwamoto, Ph.D.
Office of Medical Devices II
PMDA, Japan
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