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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

Current Landscape for Global Regulatory Acceptance of Real-World Evidence for Medical Devices

Perspectives from the RAPID Global Regulatory Acceptance Group.

By Kenneth Cavanaugh, PhD; Aaron Lottes, PhD; Melanie Raska; Alexia Bwensa; Megan Estes, PhD; Misti Malone, PhD; Rajesh Shah, MD; and Marti Velezis

United States Regulatory Perspectives on Paclitaxel in PAD

Moderator Dr. Gary Ansel asks representatives from the FDA’s Center for Devices and Radiological Health about controlling for ascertainment and investigator bias in future vascular device trials, potential changes for drug-based device approvals, how the agency weighs the level of data required for approval of new vascular devices, the statistical strength of the data from general use studies, and the level of data needed to update FDA’s position on paclitaxel-containing devices.

With Eleni Whatley, PhD; Misti Malone, PhD; Sara Royce, PhD; and Kenneth Cavanaugh, 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