Background
Methods
Results
Intervention | Product/manufacturer | Indication | Year of CE mark by NB/notified body | Year of reimbursement application | Year of FDA approval | Time between EU and USA approval |
---|---|---|---|---|---|---|
1. Percutaneous pulmonary valve implantation for right ventricular outflow tract dysfunction in patients with congenital heart defects | Melody™/Medtronic | Patients born with a dysfunctional conduit of the right ventricular outflow tract (RVOT) | 2006 | 2008 | 2010 | 4 years |
Jan: HDE Melody™ | ||||||
2. Percutaneous aortic valve replacement/TAVI | Edwards SAPIEN XT™/Edwards Lifesciences | Inoperable or high-risk patients with severe aortic valve stenosis | 2010 | 2008 | 2014 | 4 years |
2011 | Updates: 2009, 2010, 2011 | Jan: PMA | 3 years | |||
CoreValve®
| ||||||
CoreValve®/Medtronic | June: PMA | |||||
Edwards SAPIEN XT™ | ||||||
3. Cardiac contractility modulation (CCM) for heart failure | Optimizer™ III/Impulse Dynamics | Patients with symptomatic heart failure, NYHA Stadium ≥ II and normal QRC complex in ECG | 2007 | 2008 | No PMA | - |
Updates: 2009, 2010 | ||||||
4. Percutaneous transluminal angioplasty (PTA) of periphery arteries with drug-eluting balloon (DEB) | In.Pact™ Amphirion + Admiral/Medtronic | Patients with peripheral artery diseases, including extracranial carotid and vertebral artery disease, upper extremity artery disease, mesenteric artery disease, renal artery disease as well as lower extremity artery disease | In.Pact™: 2009 | 2013 | 2014 | 5 years |
Lutonix DCB™:2011 | July: Lutonix DCB™ | |||||
Lutonix DCB™/Bard-Lutonix | ||||||
Cotavance™: 2011 | ||||||
Cotavance™/Bayer Schering | ||||||
Advance PTX®: 2011 LEGflow™: 2011/2012 | ||||||
Advance 18 PTX®/Cook Medical | ||||||
LEGflow™/Cardionovum | ||||||
ELUTAX SV™/Aachen Resonance | Elutax SV™: 2013 | |||||
Freeway™: year not disclosed | ||||||
Freeway™/Eurocor | ||||||
5. Percutaneous transluminal coronary angioplasty (PTCA) with drug-eluting balloon (DEB) | Dior® PCB/Eurocor SeQuent® Please DCB/Braun Melsungen AG | Patients with coronary artery diseases with in-stent-restenosis (ISR), ostium stenosis, stenosis of small coronary vessel disease (SVD) and de-novo lesion of coronary vessels | Dior® PCB: 2007 | 2009 | No PMA | - |
SeQuent® Please DCB: 2009 | Update: 2013 | |||||
In.Pact™ Admiral: 2009 | ||||||
In.Pact™ Admiral/Medtronic | ||||||
Cotavance™/Bayer Schering | Cotavance™: 2011 | |||||
6. Percutaneous repair of mitral regurgitation with the MitraClip | MitraClip®/Abbott | Patients with moderately severe or severe mitral regurgitation (grade 3+ or 4+); both operable and inoperable patients | 2008 | 2010 | 2013 | 5 years |
Update: 2012 | March: PMA | |||||
MitraClip®/Abbott | ||||||
7. Renal Denervation | Symplicity™ RDN/Medtronic | Patients with therapy resistant hypertonia after unsuccessful treatment (no blood pressure decrease) with at least 3 antihypertensive medicaments | 2008 | 2011 | No PMA | - |
Update: 2012 | ||||||
8. Endovascular repair of aortic aneurysms | Zenith® Fenestrated AAA Endovascular Graft/Cook Medical | Patients with abdominal aortic aneurysm and/or iliacal aneurysm having morphology suitable for endovascular repair | Zenith® Fenestrated AAA Endovascular Graft: 2005 | 2013 | 2012 | 7 years |
Zenith® Fenestrated AAA Endovascular Graft | ||||||
Ventana™ Fenestrated System/Endologix | Ventana™ Fenestrated System: 2013 | |||||
9. Percutaneous transluminal angioplasty (PTA) with drug-eluting stents in peripheral arterial disease, upper limb and thorax |
Femoropopliteal: CYPHER® Select/Cordis | Patients with symptomatic peripheral artery disease (PAD) on arteria femoralis superficialis/SFA, below the knee/BTK, visceral arteria, iliacalarteria, upper extremities | CYPHER® Select: 2005 Zilver® PTX®: 2009 | 2014 | 2012 | 3 years |
Zilver® PTX®
| - - - | |||||
Zilver® PTX®/Cook Medical | ||||||
Innova™: 2012 | ||||||
Innova™/Boston Scientific | ||||||
S.M.A.R.T.®: 2013 XIENCE Prime BTK: 2011 | ||||||
S.M.A.R.T.®/Cordis | ||||||
Infrapopliteal: | Yukon®: 2011 | |||||
PROMUS Element™ Plus | ||||||
XIENCE® Prime BTK/Abbott | ||||||
DES BTK: 2012 | ||||||
Yukon®/Translumina | ||||||
PROMUS Element™Plus | ||||||
DES BTK/Boston Scientific | ||||||
10. Percutaneous left atrial appendage closure for the prevention of thromboembolic events in patients with atrial fibrillation | Watchman® LAA Closure Technology/Atritech-Boston Scientific | Patients with atrial fibrillation (AF)/flutter/cardiac arrhythmia/abnormal heart rhythm to prevent thromboembolic events such as ischaemic stroke | Watchman® LAA: 2005, 2012 (extended use) | 2011 | No PMA | - - - |
Update: 2014 | ||||||
AMPLATZER™ Cardiac Plug/St. Jude Medical | AMPLATZERTM
Cardiac Plug: 2008 | |||||
WaveCrest™: 2013 | ||||||
Coherex WaveCrest™ LAA Occlusion System/Coherex Medical |
Market authorisation granted
Intervention | Product | Highest level of evidence at time of pre-reimbursement assessment (Austria) | LoE | Highest level of evidence: FDA application/approval (USA) | LoE |
---|---|---|---|---|---|
1. Percutaneous pulmonary valve implantation for right ventricular outflow tract dysfunction in patients with congenital heart defects | Melody™ | NB 2006 | FDA 2010 | 4 | |
2008 [14]: 4 retrospective + prospective case series, 8–68 pts | 5 | HDE approval based on 1 prospective case series 99 pts, requirement of 2 post-approval studies with 5y FU [13] | |||
2. Percutaneous aortic valve replacement/ TAVI | CoreValve®
| 2007 | FDA 2014 | 2 | |
SAPIEN XT™ | 2008 [16]: retrospective + prospective 10 case series, 8–86 pts | 5 | CoreValve® PMA approval based on 1 RCT, 656 pts [15] (CoreValve U.S. Pivotal Trial), requirement for post-approval study on extreme risk patients. | ||
4 | |||||
4 | SAPIEN XT™ PMA approval based on 1 RCT, 560 pts [17] (PARTNER II), requirement for post-approval study on inoperable patients cohort | 2 | |||
2 | |||||
2011 [20]: see 2008 + 2009 + 2010 + 1 RCT, 358 pts (PARTNER I) | |||||
3. Cardiac contractility modulation (CCM) for heart failure | Optimizer™ III/IV | NB 2007 | - | - | |
2008 [21]: 2 RCTs, 49/164 pts (FIX-HF-4/ OPTIMIZER) +2 case series 13/25 pts) | 2 |
IDE Status: Optimizer™ III Optimizer™ III/IV Trial FIX-HF-5 (Evaluate Safety and Efficacy of the OPTIMIZER®) ongoing | |||
2009 [22]: see 2008 + 1 RCT-Protokoll, 428 pts (FIX-HF-5/ OPTIMIZER) | 2 | ||||
2010 [23]: see 2009 | 2 | ||||
4. Percutaneous transluminal angioplasty (PTA) of periphery arteries with drug-eluting balloon (DEB) | In.Pact™ Amphirion + Admiral | NB 2009/11/12/13 | FDA 2014 | 1 + 3 | |
2013 [25]: 4 RCTs, 50–102 pts(2 × In.Pact™ DEBELLUM, PACIFIER, 2 × Cotovance™ THUNDER, FemPac) +2 cohort studies (registries: In.Pact™ Admiral, In.Pact™ Amphirion) | 1-2 | Lutonix DCB® PMA based on LEVANT 2 RCT, 476 pts + LEVANT 2 registry, 657 pts. [24] | |||
Lutonix DCB®
| |||||
Cotavance™ | |||||
Advance 18 PTX®
|
IDE Status: In.Pact™ Admiral based on SFA I and SFA II RCT, 331 pts | ||||
LEGflow™ |
No IDE Status: Cotavance™ (IDE suspended), Advance 18 PTX (only EU), LEGflow™ (RAPID trial EU),Freeway™ (only EU) | ||||
ELUTAX SV™ | |||||
Freeway™ | |||||
5. Percutaneous transluminal coronary angioplasty (PTCA) with drug-eluting balloon (DEB) | Dior® PCBr | NB 2007/09/11 | - | - | |
SeQuent® DCB In.Pact™ Admiral | 2009 [26]: 2 RCTs, 52/108 pts (2x Cotavance™ PACCOCATH I, II) | 1-2 |
IDE Status: In.Pact™ Admiral/ Medtronic based on SFA I and SFA II RCT, 331 pts | ||
Cotavance™ | 2013 [27]: 5 RCTs for ISR, 50–271 pts (4 × SeQuent® PEPCAD II-IV + 1 × Cotavance™ PACCOCATH II FU) +1 RCT for SVD, 60 pts (Dior® PICCOLETO) +1 RCT for de-novo lesions, 84 pts (SeQuent®) | 1-2 |
No IDE Status :Dior® PCB (only EU), SeQuent® DCB: (only EU), Cotavance™ (IDE suspended) | ||
6. Percutaneous repair of mitral regurgitation with the MitraClip | MitraClip®/Abbott | NB 2008 | 4 | FDA 2013 | |
2 | MitraClip® PMA approval based on EVEREST II RCT, 279 pts., EVEREST II high-risk registry (EVEREST II HRR), 78 pts and EVEREST II Cont. access registry (REALISM HR), 853 pts [29], requirement of 2 post-approval studies (registries) | 2 + 3 | |||
7. Renal denervation | Symplicity™ RDN/Medtronic | NB 2008 | - | - | |
2011 [31]: 1 prospective case series (SYMPLICITY HTN-1), 50 pts; 1 RCT, 106 pts. (SYMPLICITY HTN-2) | 4, 2 |
IDE Status: IDE approval study SYMPLICITY HTN-3, 535 pts. failed; 2014 approval process suspended [32], IDE approval study SYMPLICITY HTN-4 ongoing | |||
4, 2 | |||||
2012 [33]: 2011+ 1 case series, 153 pts. (FU SYMPLICITY HTN-1) | |||||
8. Endovascular repair of aortic aneurysms | Zenith® Fenestrated AAA Endovascular Graft | NB 2005/13 | FDA 2012 | 4 | |
2013 [34]: 2 HTAs +4 SR based on 1 (non-randomised) controlled study, 187 pts +7-20 case series, 196–368 pts | 3 | Zenith® Fenestrated AAA Endovascular Graft PMA approval based on 1 (historic case-) controlled study, 42 pts [35], requirement of a long-term follow-up study. | |||
Ventana™ Fenestrated System | |||||
IDE Status: Ventana™ Fenestrated System | |||||
9. Percutaneous transluminal angioplasty (PTA) with drug-eluting stents in peripheral arterial disease, upper limb and thorax |
Femoropopliteal: | NB 2009/ 12/13 | 1 + 2 1 + 2 | FDA 2012 Zilver® PTX® PMA approval based on Zilver PTX randomised study, 479 pts. [37] | 2 |
Zilver® PTX® Innova™ | 2014 [36]: Femoropopliteal
| ||||
S.M.A.R.T.®
| 3 RCTs, 36–479 pts (1 × Zilver® PTX study, 2 × S.M.A.R.T.® SCIROCCO I + II) +1 non-randomised CTs, 93 pts (Zilver®) +1 case series, 787 pts. | IDE Status: S.M.A.R.T.® Vascular Stent System No IDE Status: Innova™ Peripheral Vascular DES System (MAJESTIC in Australia, New Zealand, EU); XIENCE® Prime BTK; | |||
Infrapopliteal: | |||||
XIENCE® Prime BTK |
Infrapopliteal
| Yukon®; PROMUS Element™PlusDES BTK; CYPHER® Select (discontinued to be marketed) | |||
Yukon®
| 4 RCTs, 50–200 pts (1 × XIENCE® DESTINY, 1 × Yukon® YUKON-BTK, 2× CYPHER® ACHILLES) +3 non-randomised CTs, 58–103 pts +3 case series, 114–146 pts (all CYPHER® Select) | ||||
PROMUS Element™PlusDES BTK | |||||
CYPHER® Select | |||||
10. Percutaneous left atrial appendage closure for the prevention of thromboembolic events in patients with atrial fibrillation | Watchman® LAA Closure Technology | NB 2005/08/12/13 | 4 + 5 | - | - |
2011 [38]: 4 case series, 64–180 pts; 1 cohort study/ registry, 73 pts; 1 RCT, 542 pts (Watchman® PROTECT AF) | 2009: Watchman® LAA Closure Technology PMA approval based on RCT, 707 pts (PROTECT AF) declined[39] | ||||
AMPLATZER™ Cardiac Plug | |||||
3 + 2 | |||||
Coherex WaveCrest™ LAA Occlusion System | 2014 [40]: 2011 + 3 FU studies of PROTECT AF + |
IDE Status: Watchman® LAA Closure, re-application with RCT PREVAIL, 407 pts; AMPLATZER™ Cardiac Plug (RESPECT), 980 pts | |||
3 case series, 52–86 pts +1 cohort study/ registry, n/a; 2 prospective CTs, 80/150 pts |