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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

Melodyâ„¢/Medtronic

Patients born with a dysfunctional conduit of the right ventricular outflow tract (RVOT)

2006

2008

2010

4 years

Jan: HDE Melodyâ„¢

2. Percutaneous aortic valve replacement/TAVI

Edwards SAPIEN XTâ„¢/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 XTâ„¢

3. Cardiac contractility modulation (CCM) for heart failure

Optimizerâ„¢ 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.Pactâ„¢ 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.Pactâ„¢: 2009

2013

2014

5 years

Lutonix DCBâ„¢:2011

July: Lutonix DCBâ„¢

Lutonix DCBâ„¢/Bard-Lutonix

Cotavanceâ„¢: 2011

Cotavanceâ„¢/Bayer Schering

Advance PTX®: 2011

LEGflowâ„¢: 2011/2012

Advance 18 PTX®/Cook Medical

LEGflowâ„¢/Cardionovum

ELUTAX SVâ„¢/Aachen Resonance

Elutax SVâ„¢: 2013

Freewayâ„¢: year not disclosed

Freewayâ„¢/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.Pactâ„¢ Admiral: 2009

In.Pactâ„¢ Admiral/Medtronic

Cotavanceâ„¢/Bayer Schering

Cotavanceâ„¢: 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

Symplicityâ„¢ 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

Ventanaâ„¢ Fenestrated System/Endologix

Ventanaâ„¢ 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

 

Innovaâ„¢: 2012

Innovaâ„¢/Boston Scientific

S.M.A.R.T.®: 2013 XIENCE Prime BTK: 2011

S.M.A.R.T.®/Cordis

Infrapopliteal:

Yukon®: 2011

PROMUS Elementâ„¢ Plus

XIENCE® Prime BTK/Abbott

DES BTK: 2012

Yukon®/Translumina

PROMUS Elementâ„¢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

AMPLATZERâ„¢ Cardiac Plug/St. Jude Medical

AMPLATZERTM

Cardiac Plug: 2008

WaveCrestâ„¢: 2013

Coherex WaveCrestâ„¢ LAA Occlusion System/Coherex Medical