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Table 2 Evidence available at time of pre-reimbursement assessment in Austria and at time of FDA approval, levels of evidence

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

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.

2009 [18]: see 2008 + 4 case series, 12–646 pts 2010 [19]: see 2008 + 2009 + 6 cohort studies (registries), 4 HTAs

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

 

2010 [28]: prospective case series (EVEREST I/II), 107 pts 2012 [30]: 2010 + 10 case series +1 RCT, 279 pts (EVEREST II)

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

  1. Legend: pts.: patients; NB: notified bodies; RCT: randomised controlled trial; FDA: Food and Drug Administration; IDE: investigational device exemption; PMA: premarket approval; HDE: humanitarian device exemption.