J Heart Lung Transplant. 2010; 29: ISHLT 5 ( ) Number of Transplants 4,484 4,452 4,425 4,314 4,245 3,943 3,700 4,251 4,216 4,021

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1 5( ) () () () ,193 2,174 2,728 3,151 3,381 4,021 4,216 4,251 4,425 4,484 4,452 4,314 4,245 3,943 3,700 3,571 3,528 3,408 3,367 3,294 3,370 3,406 3,389 3, CyA BTT ISHLT J Heart Lung Transplant. 2010; 29: Number of Transplants Jarvik 7 1 st patient (1982) VAD(1980) Survived 112 days

2 VAD (Nipro VAD54 vs VAD: 20) () ADULT HEART TRANSPLANTATION Kaplan-Meier Survival by VAD usage (Transplants: 1/1999-6/2009) Survival (%) Conditional on Survival to 6 Months No pair-wise comparisons are statistically significant at p < 0.05 Pulsatile flow (N=2,793) No LVAD / No Inotropes (N=7,089) ISHLT 2011 Years J Heart Lung Transplant Oct; 30 (10): Continuous flow (N=776) No LVAD / Inotropes (N=7,469) Number of VAD Therapy in Univ. of Tokyo Hosp. Clinical trial ilvad Approval ilvad Jarvik2000 DuraHeart EVAHEART HeartMate XVE Paracorporeal VAD Nipro (Implantable Rotary VAD: 20pts, Nipro VAD54 pts)

3 Novacor carried serious problems in Insurance Reimbursement Rule Novacor BTT Device Cardiovascular Med-Surg 2005;7(2): LVAD :(H17,18) : (H19) LVAD(H20) (H21) (H22 ) : VAD(H21, ) (H23) (H21) J-MACS(H22, PMDA) EVAHEART, DuraHeart () (28) DuraHeart EVAHEART ISO DuraHeart EVAHEART 15 24

4 GLP GCP QMS/GQP GPSP/GVP GLP= GCP= QMS= GQP= GPSP= GVP= WG WG WG WG WG WG WG H1 A B C D E F G H

5 TAH/VAD % reliability, 60% confidence level 6 80% reliability, 80% confidence level WG TAH/VAD (EMC) in vitro in vivo ANNEX A ANNEX B ANNEX C Yamane T, Kyo S, Matsuda H, et al.: Japanese Guidance for Ventricular Assist Devices/Total Artificial Hearts, Artificial Organs, Vol.34, No.9, 2010 NEDO VAD 268 VAD 63

6 NEDO VAD 8908on going TAH/VAD H20.4.4) Feasibility study 5 Pivotal study 15 Feasibility study 3 Pivotal study 6 DT 12 BTT 1 DT 24 DT WG DuraHeart & EVAHEART 2004 DuraHeart EVAHEART DuraHeart EVAHEART DuraHeart ISO Circulastory Support Devices J-MACS ( ) (1) (2)

7 BSA NYHA:- D ( ) ACEARB IABP 65( 65) stage D, NYHA QOL QOL BSA NYHA:- D ( ) ACEARB IABP 65( 65) stage D, NYHA QOL QOL J-MACS LVAD LVAD(23) EVAHEART 18 Jarvik DuraHeart

8 (Kaplan-Meyer) Kaplan-Meier 1.8 (n=11) (719=53%) (n=36) 6 + (27=64%) 7 VAD Japanese registry for Mechanically Assisted Circulatory SupportJ-MACS 61 DC Data Base VAD EVAHEART 32 DuraHeart LVAD ( ) BVAD BVAD ( 95%) 1(1.7%) 1(1.7%) 1(1.7%)

9 New Strategy of VAD therapy Bridge to transplantation (BTT) Bridge to recovery (BTR) Destination Therapy (DT) New Strategy of VAD therapy Bridge to transplantation (BTT) Bridge to recovery (BTR) Destination Therapy (DT) Bridge to decision implantable VAD Bridge to bridge implantable VAD Bridge to therapy BTR Bridge to candidacy BTT NIPRO VADBridge to Bridge LVAD:534 BTR=Bridge to Therapy -blocker, ACEI, ARB) (MVPDor) () BTR us markets for ventricular assist devices 2008; Millennium Research Group, Inc.

10 ( ) ( ) Gojo S, Kyo S, Nishimura S et al. Cardiac resurrection after bone-marrow-derived mononuclear cell transplantation during left ventricular assist device support. Ann Thorac Surg 2007:83: ? (3050/) VAD VAD LVAD : destination therapy VAD LVAD LVAD

11 LVAD : destination therapy VAD LVAD LVAD % Survival Implant Dates: June 23, 2006 March 31, 2009 Device Strategy at Implant Destination = 120, deaths = 49 BTT = 1184, deaths = 213 p=.01 Event: Death (censored at transplant or recovery) Months after Device Implant LVAD : destination therapy VAD LVAD LVAD

12 BTT(?) BTT ECMO (<1) VAD() Excor (Berlin Heart) Clinical trial : Berlin Heart Excor 10ml 25ml 30ml 50ml 60ml 10ml Jarvik Heart Inc. PumpKIN Preclinical Program NCVC, Mitsubishi Pump NEDO Project ( ) LVAD : HVAD (HeartWare):145g destination therapy VAD DuraHeart (Terumo) DuraHeart2 (Prototype) EVAHEART LVAD 110g LVAD

13 (20) LVAD LVAD : destination therapy VAD 53 LVAD NCVC() LVAD Need of Implantable LVAD Center (LVAD) LVAD (/) CRT 5 (100/)

14 3,000 2,500 VAD ( ) 3( , ) VAD New Hospital Open 2,000 1,500 1, Univ. of Tokyo Tokyo Metropolitan Geriatric Medical Center Univ. of Tokyo Novacor carried serious problems in Insurance Reimbursement Rule VAD? : / /6/ VAD Novacor LVAD 0 Op (3m) 1y cost 2y cost 3y cost Cardiovascular Med-Surg 2005;7(2): (n=50), Novacor(n=5):

15 VAS() VAS () ( )() VAS VAS VAD (61) VAD (Nipro VAD54 vs VAD: 20) VAS(40) () 12,000,000 10,000,000 8,000,000 6,000, / (1511) VAS VAS / (3448) 2 59/ (117) 4,000,000 2,000, /3 06/11 08/ () (8) 1511(189/) VAS(3) 1493 VAS(15) 3448(230/) (3) 878 (2) 117( 59/) 7447

16 () 1,000, , , , ,000 0 (6) 1,400, / 75444/ 68125/ 76393/ 1,200,000 05/9 06/3 06/9 07/3 07/9 08/3 08/ / / / / () (-) (-) :( ) SpO 2 PT-INR

17 (2010) Novacor(2010) DuraHeart(2011) DuraHeart(2012) VAD2+ (K603-1,2,3,) DuraHeart+(K604-1,2,3,4) EVAHEARTDuraHeart(100) LVAD(24) LVAD : () BTT :60 DT

18 ( ) () ()