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)
| 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 |