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FDA Paclitaxel Safety Panel Preview
An interview with FDA CDRH representatives discussing the upcoming advisory panel meeting to review concerns and current data on paclitaxel-eluting device use.
By Kenneth Cavanaugh, PhD, and Misti Malone, PhD
Carotid Stents and Embolic Protection Devices
Mechanisms of failure and current requirements for preclinical analyses.
By Alan R. Pelton, PhD, and Roy K. Greenberg, MD
Evaluation of Renal Artery Stenting
Clinical study design, nonclinical testing, and regulatory considerations for appropriate use of this technology.
By Kenneth J. Cavanaugh, Jr, PhD
Highlights From the VIVA Vascular Leaders Forum on Paclitaxel Safety
Points of consensus, contention, and paths forward.
CAS Approval and Reimbursement
Let's not forget about the individual patient.
By DOROTHY B. ABEL, with ANGELA C. SMITH AND KENNETH J. CAVANAUGH
Regulation of Carotid Artery Stents and Embolic Protection Devices in the United States
A history of, and perspectives on, FDA regulation of carotid stents and associated embolic protection devices over the years.
By Sadaf A. Toor, MS; Kenneth J. Cavanaugh Jr, PhD; and Lisa M. Lim, PhD
The State of CAS
By William A. Gray, MD, and Sumaira Macdonald, MBChB, FRCP, FRCR, PhD
Lower-Extremity Intervention: Meeting the Challenge?
By Takao Ohki, MD, PhD, Chief Medical Editor