Clinical evaluation of cardiovascular devices: principles, problems, and proposals for European regulatory reform: Report of a policy conference of the European Society of Cardiology

VARC consensus report: the FDA perspective

(2011) M. G. Hillebrenner et al.   EUROPEAN HEART JOURNAL

Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium

(2011) M. B. Leon et al.   EUROPEAN HEART JOURNAL

A Historical Perspective on Clinical Trials Innovation and Leadership

(2011) David L. DeMets   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Transferability of data between different drug-eluting stents

(2011) Michael Magro et al.   EuroIntervention

Medical Devices and the FDA Approval Process: Balancing Safety and Innovation

(2010)   ARCHIVES OF INTERNAL MEDICINE

Complications Associated With Revision of Sprint Fidelis Leads

(2010) Ratika Parkash et al.   CIRCULATION

Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)

(2010) et al.   EUROPEAN HEART JOURNAL

NICE evaluation of transmyocardial laser revascularisation and percutaneous laser revascularisation for refractory angina

(2010) P. M. Schofield et al.   HEART

Achieving Meaningful Device Surveillance

(2010) John S. Rumsfeld et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Automated Surveillance to Detect Postprocedure Safety Signals of Approved Cardiovascular Devices

(2010) Frederic S. Resnic et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Comparison between Different Speckle Tracking and Color Tissue Doppler Techniques to Measure Global and Regional Myocardial Deformation in Children

(2010) Laurens P. Koopman et al.   JOURNAL OF THE AMERICAN SOCIETY OF ECHOCARDIOGRAPHY

Assessment of Myocardial Deformation in Children Using Digital Imaging and Communications in Medicine (DICOM) Data and Vendor Independent Speckle Tracking Software

(2010) Laurens P. Koopman et al.   JOURNAL OF THE AMERICAN SOCIETY OF ECHOCARDIOGRAPHY

Modernizing Device Regulation

(2010) Alan M. Garber   NEW ENGLAND JOURNAL OF MEDICINE

Study Design of the CLOSURE I Trial

(2010) Anthony J. Furlan et al.   STROKE

Left to Their Own Devices: Breakdowns in United States Medical Device Premarket Review

(2010) Jonas Zajac Hines et al.   PLOS MEDICINE

Cancer Risks and Radiation Exposure From Computed Tomographic Scans

(2009) Rita F. Redberg   ARCHIVES OF INTERNAL MEDICINE

Radiation Dose Associated With Common Computed Tomography Examinations and the Associated Lifetime Attributable Risk of Cancer

(2009) Rebecca Smith-Bindman   ARCHIVES OF INTERNAL MEDICINE

Double standards in the world of ASD and PFO management: Closure for paradoxical embolism

(2009) John D. Carroll   CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS

Percutaneous Device Closure of Patent Foramen Ovale for Secondary Stroke Prevention

(2009) Patrick T. O'Gara et al.   CIRCULATION

The First Generation of Angioplasty

(2009) William W. O'Neill et al.   Circulation-Cardiovascular Interventions

Stroke and migraine: a cardiologist's headache

(2009) B. Meier   HEART

Assessing the impact of England's National Health Service R&D Health Technology Assessment program using the “payback” approach

(2009) James Raftery et al.   INTERNATIONAL JOURNAL OF TECHNOLOGY ASSESSMENT IN HEALTH CARE

The HTA Core Model: A novel method for producing and reporting health technology assessments

(2009) Kristian Lampe et al.   INTERNATIONAL JOURNAL OF TECHNOLOGY ASSESSMENT IN HEALTH CARE

Scientific Evidence Underlying the ACC/AHA Clinical Practice Guidelines

(2009) Pierluigi Tricoci   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Strength of Study Evidence Examined by the FDA in Premarket Approval of Cardiovascular Devices

(2009) Sanket S. Dhruva   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Health Insurers and Medical-Imaging Policy — A Work in Progress

(2009) John K. Iglehart   NEW ENGLAND JOURNAL OF MEDICINE

Postmarket evaluation of breakthrough technologies

(2008) Sunil V. Rao et al.   AMERICAN HEART JOURNAL

Assessment of left ventricular volumes using simplified 3-D echocardiography and computed tomography – a phantom and clinical study

(2008) Mattias Mårtensson et al.   Cardiovascular Ultrasound

The off-versus on-label use of medical devices in interventional cardiovascular medicine?: Clarifying the ambiguity between regulatory labeling and clinical decision making, Part III: Structural heart disease interventions

(2008) Ralf Holzer et al.   CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS

Patent Foramen Ovale in Cryptogenic Stroke: Not to Close

(2008) Steven R. Messé et al.   CIRCULATION

Patent Foramen Ovale and Cryptogenic Stroke: To Close or Not to Close? Closure: What Else!

(2008) Stephan Windecker et al.   CIRCULATION

Results of the Predictors of Response to CRT (PROSPECT) Trial

(2008) Eugene S. Chung et al.   CIRCULATION

Migraine Intervention With STARFlex Technology (MIST) Trial

(2008) Andrew Dowson et al.   CIRCULATION

HRS/EHRA Expert Consensus on the Monitoring of Cardiovascular Implantable Electronic Devices (CIEDs): Description of Techniques, Indications, Personnel, Frequency and Ethical Considerations: Developed in partnership with the Heart Rhythm Society (HRS) and the European Heart Rhythm Association (EHRA); and in collaboration with the American College of Cardiology (ACC), the American Heart Association (AHA), the European Society of Cardiology (ESC), the Heart Failure Association of ESC (HFA), and the Heart Failure Society of America (HFSA). Endorsed by the Heart Rhythm Society, the European Heart Rhythm Association (a registered branch of the ESC), the American College of Cardiology, the American Heart Association

(2008) B. L. Wilkoff et al.   EUROPACE

Meeting Report: ESC Forum on Drug Eluting Stents European Heart House, Nice, 27-28 September 2007

(2008) et al.   EUROPEAN HEART JOURNAL

Two-year clinical outcomes after paclitaxel-eluting stent or brachytherapy treatment for bare metal stent restenosis: the TAXUS V ISR trial

(2008) S. G. Ellis et al.   EUROPEAN HEART JOURNAL

Left ventricular remodelling and systolic function measurement with 64 multi-slice computed tomography versus second harmonic echocardiography in patients with coronary artery disease: A double blind study

(2008) Alberto Palazzuoli et al.   EUROPEAN JOURNAL OF RADIOLOGY

Outcome of the Fidelis implantable cardioverter-defibrillator lead advisory: A report from the Canadian Heart Rhythm Society Device Advisory Committee

(2008) Andrew D. Krahn et al.   HEART RHYTHM

3-Year Follow-Up of the SISR (Sirolimus-Eluting Stents Versus Vascular Brachytherapy for In-Stent Restenosis) Trial

(2008) David R. Holmes et al.   JACC-Cardiovascular Interventions

To Replace or Not to Replace: A Systematic Approach to Respond to Device Advisories

(2008) SILVIA G. PRIORI et al.   JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY

Feasibility and Accuracy of Different Techniques of Two-Dimensional Speckle Based Strain and Validation With Harmonic Phase Magnetic Resonance Imaging

(2008) Manish Bansal et al.   JOURNAL OF THE AMERICAN SOCIETY OF ECHOCARDIOGRAPHY

Guidelines for reporting mortality and morbidity after cardiac valve interventions

(2008) Cary W. Akins et al.   JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY

Semper Fidelis — Consumer Protection for Patients with Implanted Medical Devices

(2008) William H. Maisel   NEW ENGLAND JOURNAL OF MEDICINE

A Changing Paradigm in the Study and Adoption of Emerging Health Care Technologies: Coverage With Evidence Development

(2008) Paul E. Wallner et al.   Journal of the American College of Radiology