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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 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 Company Names Company Names Company Names Company Names Company Names Company Names 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 investigatorinitiated clinical trial. CE mark PMDA FDA Conformity to CE mark Developing countries • Alternation for surgery • Economical reason Developed countries • Safety • efficacy • cost-effectiveness Un-approval device in Japan Category 1 Availability Approved & available world wide except Japan Device ・Large stent (new generation) ・ADO II, musc VSD occluder ・Melody V, Sapien V（TPVI） 2 ・Melody for other valves Not approved but used as Off-label in US (and Japan) ・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 Occluder-1 Japan US Europe East Asia ASEAN （Korea, Taiwan） Amplatzer Septal occluder 〇 〇 〇 〇 〇 Cribriform 〇 〇 〇 〇 〇 ◯ 〇 〇 〇 〇 〇 〇 〇 〇 〇 〇 〇 PFO occluder Duct occluder 〇 Duct occluder II 〇 Duct occluder II AS 〇 MusVSD occ. Perimem VSD occ. 〇 〇 〇 〇 〇 〇 〇 Vascular Plug 〇 〇 〇 〇 〇 Vascular Plug II 〇 〇 〇 〇 〇 〇 〇 〇 〇 〇 〇 Vascular Plug III Vascular Plug IV 〇 〇 Occluder-2 Japan US Europe East Asia ASEAN （Korea, Taiwan） Occlutech Septal occ. Figulla Flex II 〇 〇 〇 〇 Duct occluder 〇 〇 〇 VSD occluder 〇 〇 〇 〇 Duct occluder 〇 〇 VSD occluder 〇 〇 Vascular Plug 〇 〇 Septal occluder 〇 〇(Korea) 〇 Duct occluder 〇 〇(Korea) 〇 VSD occluder 〇 〇 〇 〇 〇 〇 LifeTech Septal occluder Cocoon pfm Nit-occlude Le VSD occluder 〇 Percutaneous Pulmonary valve implantation Japan US Europe East Asia ASEAN （Korea, Taiwan） Medtronic Melody 〇 〇 Edwards Sapien 〇HDE 〇 △ MedTech Venus P valve Clinical trial Clinical trial Medtronic Harmony Clinical trial 〇 △ Stent Japan US Europe East Asia ASEAN （Korea, Taiwan） Cordis Palmaz NuMed CP Cordis Genesis 〇 〇 〇 〇 △ Clinical trial PMA for CoA 〇 〇（Taiwan) 〇 Available but off-label 〇 〇（Taiwan) 〇 Andramed Andra Bard Vaｌeo OptiMed OptiMed PDA Available but off-label 〇 △ 〇 △ 〇 △ Stent for Pediatric use has not been approved for decades because of difficult conduction of industryinitiated 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 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 • Registration； 32patients • Age；3-36（median 11) yo. • 3-9yo； 12 • 10-19yo； 13 • 20yo～； 7 • Pathophysiology Bi-ventricular physiology 27 Single ventricular physiology 5 • Weight；12-69（median38） kg • 10-14kg； 2 • 15-19kg; 5 • 20-24kg; 2 • 25-29kg; 3 • 30kg ～; 30 • Indication Pressure gradient Stenosis ratio RVSP SpO2(Fontan) • Completely stent implantaｔion；22 patients 6 22 3 1 • 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. Regulatory • Ease regulation • Simplified of clinical trial • Adjusting regulation between US and Japan HBD for children Industry • Cost of approval process • Market scale • Contribution to society Public grant Research & development of new device Academia • Physician oriented clinical trial • Enlighten and education • Certification system
