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Table 1 Cardio-vascular interventions and medical devices, years of approval in Europe and in the USA, year of reimbursement-application in Austria (2008–2014)

From: Contrasting clinical evidence for market authorisation of cardio-vascular devices in Europe and the USA: a systematic analysis of 10 devices based on Austrian pre-reimbursement assessments

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®/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
ELUTAX SV™/Aachen Resonance Elutax SV™: 2013
Freeway™: year not disclosed
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
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
Infrapopliteal: Yukon®: 2011
PROMUS Element™ Plus
XIENCE® Prime BTK/Abbott
DES BTK: 2012
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