Supplemental Appendix

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Supplemental Appendix Appendix Table 1. Sub-Categorization of Medical Devices Included in Study Sample Novel Medical Devices (N = 309)

Examples

Cardiovascular Cardiac (ventricular) assist devices Cardiac prosthetic devices Cardiac rhythm management Interventional cardiology

Ventricular assist device Transcatheter heart valve Implantable cardioverter defibrillators Drug-eluting coronary stent

Electrophysiology

Cardiac ablation catheter

Cardiac surgery and other

Vascular closure device

Neurologic Neuromodulation Neurology therapeutic devices Other neurology

Deep brain stimulation device Intracranial aneurysm flow diverter Neurodiagnostic electrodes

Orthopedic Joint reconstruction Spinal and other orthopedic

Knee replacement Intervertebral fusion device

Appendix Table 2. Results from Multivariable Linear Regression Model of Time Differentials between CE Marking and FDA Approval

Characteristic

Coefficient (months)

95% confidence interval (CI)

P value

CE Marking year 2005

1 [Reference]

2006

-4.69

(-17.5-8.10)

0.47

2007

0.04

(-10.3-10.4)

0.99

2008

-0.75

(-12.2-10.7)

0.90

2009

-3.13

(-13.6-7.4)

0.56

2010

-6.45

(-16.8-3.9)

0.22

Therapeutic sub-category Cardiac assist devices

1 [Reference]

Cardiac prosthetic devices

0.25

(-10.9-11.4)

0.97

Cardiac rhythm management

-12.8

(-23.4--2.06)

0.02

Interventional cardiology

-2.04

(-11.1-7.0)

0.66

Electrophysiology

-2.14

(-14.5-10.2)

0.73

Cardiac surgery and other

-3.98

(-15.7-7.70)

0.50

Neuromodulation devices

-13.7

(-31.8-4.39)

0.14

Neurology therapeutic devices

-16.0

(-32.0-0.02)

0.05

Other neurologic devices

-15.6

(-26.5--4.66)

0.01

Joint reconstruction

-4.32

(-26.7-18.0)

0.70

Spinal and other orthopedic

-5.95

(-16.0-4.04)

0.24

Yes

0.93

(-5.14-6.99)

0.76

No

1 [Reference]

5.89

(-0.23-12.0)

0.06

38.0

(29.9-46.1)