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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

RAPID Pathways’ Approach to an Urgent Safety Signal

Discussing the challenges, opportunities, and lessons learned from paclitaxel in PAD.

By Daniel J. Bertges, MD; Mitchell W. Krucoff, MD; Aaron Lottes, PhD, MBA; Misti Malone, PhD; George Papandreou, PhD; Sara Royce, PhD; and Eleni Whatley, PhD

Current Considerations on Real-World Evidence Use in FDA Regulatory Submissions

Examples and decision making from the Center for Devices and Radiological Health's Peripheral Interventional Devices Branch.

By Eleni Whatley and Misti Malone

SPEED: A New Initiative in Real-World PAD Evidence Evaluation

An overview of the FDA's new multistakeholder project to support real-world evidence evaluation for devices aimed at treating peripheral artery disease.

By 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

The Value of Propensity-Matched Registry Data for New Device Evaluation

Novel use of real-world evidence with core lab imaging to create a control group for new medical device evaluation.

By Jack L. Cronenwett, MD; Eleni Whatley, PhD; Misti Malone, PhD; Cassandra Svendsen, BSME, MSBE; Michael J. Kallok, PhD; Kenneth Ouriel, MD; and Jens Eldrup-Jorgensen, MD

Regulatory Update: Paclitaxel in 2020 and Beyond

An interview with representatives from the FDA’s Center for Devices and Radiological Health on the current state of paclitaxel-coated device use, including safety, new data, and effects on the peripheral trial landscape.

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

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

Creating CLI Teams

The VIVA Physicians' Vascular Leaders Forum offers guidance on core competencies and quality measures for establishing multidisciplinary CLI care teams.

By John H. Rundback, MD; Tony S. Das, MD; Peter A. Schneider, MD; and Michael R. Jaff, DO; on behalf of the VLF participants

Interventional Oncology: Precision in Practice

By Ripal Gandhi, MD, FSVM, and David M. Liu, MD, FRCPC, FSIR

Highlights From the VIVA Vascular Leaders Forum on Paclitaxel Safety

Points of consensus, contention, and paths forward.

Highlights From ACC

ELVO in the Big Apple: How Stroke Teams Coordinate Efficient Care in a Gridlocked Metropolis

Utilizing models of stroke transfer to improve onset-to-treatment times for stroke patients.

By Daniel Wei, BS, and Johanna T. Fifi, MD

Venous Issues Relative to CLI

Do arterial and venous disease overlap in patients with tissue loss?

By Jose I. Almeida, MD, FACS, RPVI, RVT, and Cristal Boatright, MMS, PA-C