1. Clinical Needs and Current Situations of Endovascular Treatment Devices for Pediatric Cardiology
JP Academia
HISASHI SUGIYAMA
Japanese Society of Pediatric Cardiology and Cardiac Surgery
Japanese Society of Pediatric Interventional Cardiology
Pediatric Cardiology, Tokyo Women’s Medical University

2. Disclosure Statement of Financial Interest
Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.
Affiliation/Financial Relationship
Company
Grant/Research Support
Consulting Fees/Honoraria
Major Stock Shareholder/Equity
Royalty Income
Ownership/Founder
Intellectual Property Rights
Other Financial Benefit
Company Names

3. Introduction
The modern progress and smooth introduction of new devices for catheter intervention impacts on remarkable clinical improvement in adult cardiology, while those could make a slow step in pediatric cardiology.
Time lag of the new device approval in pediatric cardiology is always a issue both in Japan , in USA, and in other countries.
In Japan, such trends shows more evident as slow introduction of catheter devices to cath.lab, since it has been taken decades to approve Amplatzer septal occluder, duct occluder, Vascular plug, RF wire and Occlutech device.
CP stent for pulmonary stenosis is now under investigator-initiated clinical trial.

4. CE mark PMDA FDA Conformity to CE mark Developed countries
Developing countries
Alternation for surgery
Economical reason
Safety
efficacy
cost-effectiveness

5. Un-approval device in Japan
Category
Availability
Device 1
Approved & available world wide except Japan
・Large stent (new generation)
・ADO II, musc VSD occluder
・Melody V, Sapien V（TPVI） 2
Not approved but used as Off-label in US (and Japan)　
・Melody for other valves
・Stent for PS
・Stent for PDA 3
Not approved in US and Japan
　（only CE mark）
・Venus P valve
・ADO-II AS
・Andra stent 4
Under developing
　（Human trial will be started）
・BVS for children
・Harmony valve

6. Occluder-1 Japan US Europe East Asia ASEAN （Korea, Taiwan） Amplatzer 〇
Septal occluder 〇
Cribriform
PFO occluder ◯
Duct occluder
Duct occluder II
Duct occluder II AS
MusVSD occ.
Perimem VSD occ.
Vascular Plug
Vascular Plug II
Vascular Plug III
Vascular Plug IV

7. Occluder-2 Japan US Europe East Asia ASEAN （Korea, Taiwan） Occlutech
Septal occ. Figulla Flex II 〇
Duct occluder
VSD occluder
LifeTech
Septal occluder
Vascular Plug
Cocoon
〇(Korea)　
〇(Korea)
pfm
Nit-occlude
Le VSD occluder

8. Percutaneous Pulmonary valve implantation
Japan US
Europe
East Asia
ASEAN
（Korea, Taiwan）
Medtronic
Melody 〇 △
Edwards
Sapien
〇HDE
MedTech
Venus P valve
Clinical trial
Harmony

9. Available but off-label
Stent　
Japan US
Europe
East Asia
ASEAN
（Korea, Taiwan）
Cordis
Palmaz 〇 △
NuMed CP
Clinical trial
PMA for CoA
〇（Taiwan)
Genesis
Available but off-label
〇（Taiwan) 　
Andramed
Andra
Bard
Vaｌeo
OptiMed
OptiMed PDA

10. Conducted by Dr. Hideshi Tomita
5/18/2018 8:22 PM
Stent for Pediatric use has not been approved for decades because of difficult conduction of industry- initiated clinical trial due to economic reason (small market and vast efforts to get approval of administration.
Investigator-Initiated Clinical Trial of CP stent for pulmonary stenosis in Japan
Conducted by Dr. Hideshi Tomita
Toshiki Kobayashi, Hitoshi Kato, Hisashi Sugiyama with coorperation of JPIC academy members
© 2007 Microsoft Corporation. All rights reserved. Microsoft、Windows、Windows Vista、およびその他の製品名は、米国およびその他の国における登録商標または商標 です。
ここに示す情報は参照だけを目的とし、発表時点での Microsoft Corporation の見解を表します。 Microsoft は変化する市況に対応する必要があり、この発表は Microsoft のコミットメントとして解釈されるものではありません。また Microsoft はこの発表日以降に提供されるあらゆる情報について、その正確性を保証できるものではありません。 Microsoft はここに示される情報について、明示、黙示、または法令を問わず保証をしません。

11. Background
Stenting for great vessel stenosis associated with congenital heart diseases has been established procedure
Although some stent approved for CoA by CE mark, no stent officially approved for pulmonary stenosis, even in US and Europe
Consequently, stenting for PS or CoA has been off-label, also in our country
Despite negotiation between our society and PMDA for longer than 20 years, no stent has officially been approved for congenital heart diseases

12. Registration； 32patients
Age；3-36（median 11) yo.
3-9yo；　　12
10-19yo； 13
20yo～；　 7
Weight；12-69（median38） kg
10-14kg； 2
15-19kg;
20-24kg;
25-29kg;
30kg ～;
Pathophysiology
Bi-ventricular physiology 　　27
Single ventricular physiology 5
Indication
　　　 Pressure gradient 　6
　 Stenosis ratio 　　 22
　 RVSP 　　 　3
　 SpO2(Fontan)　 　 　1
　Completely stent implantaｔion；22 patients

13. CP stent was approved for CoA (COAST II), and will be approved for right ventricular outflow tract conduit by FDA.
CP stent for pulmonary stenosis clinical trial will be completed in Japan by April 2017.
Comprehensive approval of the CP stent (PS, CoA, RVOT and covered CP stent) will be expected in next year.

14. Research & development of new device
Regulatory
Ease regulation
Simplified of clinical trial
Adjusting regulation between US and Japan
HBD for children
Public grant
Industry
Academia
Cost of approval process
Physician oriented clinical trial
Research & development of new device
Market scale
Enlighten and education
Contribution to society
Certification system