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FDA Response to Medical Device Regulatory Challenges

A description of initiatives designed to expedite the review process.

By Dorothy B. Abel; Andrew Farb; and Megan Moynahan

Paclitaxel Post-Panel: FDA Discusses What's Next From a Regulatory Perspective

An interview with representatives from the FDA Center for Devices and Radiological Health on the key updates to the letter to health care providers, lessons learned for future trials and follow-up protocols, and additional plans for monitoring in the future.

With Eleni Whatley, PhD, and Andrew Farb, MD

Inside the Gore TAG Device Advisory Hearing

On January 13, 2005, a panel voted to recommend approval with conditions for Gore's TAG Thoracic Endoprosthesis. The device could be the first approved in the US for the endovascular treatment of thoracic aortic aneurysms.

By Matt Pesotski, Associate Editor

An Interview With Andrew Holden, MBChB, FRANZCR, EBIR

Dr. Holden reflects on the legacy of paclitaxel and lessons learned from the controversy, research priorities for 2022, his philosophy for choosing which projects to accept, and more.

Mentors and Protégés: Conversations on Career and Craft With Andrew J. Gunn, MD, FSIR

Shakthi Kumaran Ramasamy, MD, a postdoctoral research fellow at Stanford School of Medicine, talks with Dr. Gunn about his career trajectory, research endeavors, mentorship, and more.

With Andrew J. Gunn, MD, and Shakthi Kumaran Ramasamy, MD

Double-Wire Technique for Giant Cerebral Aneurysms

Distal artery navigation for stenting giant cerebral aneurysms, aided by the double-wire technique.

By Demetrius K. Lopes, MD, and Andrew K. Johnson, MD, MS

Ask the Experts:

What is your go-to option for treating in-stent restenosis?

With Antonio Micari, MD, PhD; Prof. Dr. med. Nicolas Diehm; Michael H. Wholey, MD, MBA; Jos C. van den Berg, MD, PhD; and Andrew J. Feiring, MD, FACC, FSCAI, FAHA

Global Roundtable: Real-World Experience With Drug-Coated Balloons in AV Access

Experts discuss the current use of DCBs in AV fistulas and review how upcoming trials may influence progress in this space.

With Andrew Holden, MBChB, FRANZCR, EBIR; Farah Gillan Irani, MBBS, FRCR, FAMS; Dimitrios Karnabatidis, MD, PhD, FCIRSE; Panagiotis M. Kitrou, MD, MSc, PhD, EBIR; Bien Soo Tan, MBBS, FRCR, FAMS; and Scott O. Trerotola, MD

Panel Discussion: BTK Drug-Coated Balloons: Can They Clear the Hurdle?

Perspectives on the role of DCBs below the knee, current challenges, and considerations for future trials.

With Marianne Brodmann, MD; Edward Choke, MD; and Andrew Holden, MBChB, FRANZCR, EBIR

Successful Bailout: Key Decisions and Techniques to Master

Experts discuss when to pivot, how to escalate, and which bailout strategies deliver success in complex CTO interventions.

With Yolanda Bryce, MD, RPVI; Edward T.C. Choke, MBBS, FRCS, PhD; Andrew Holden, MD; and Bruno Migliara, MD

Ten Interventional Oncology Pitfalls

Lessons learned from complications encountered during interventional oncology procedures.

By Nicholas Fidelman, MD; Matthew D. Bucknor, MD; Paul Haste, MD; Maureen P. Kohi, MD; Ryan M. Kohlbrenner, MD; K. Pallav Kolli, MD; Kristen Lee, MD; Evan D. Lehrman, MD; Thomas M. Link, MD, PhD; and Andrew G. Taylor, MD, PhD

Dialysis Access and the Real-World Proving Ground

By Bart Dolmatch, MD, and Neghae Mawla, MD

Peripheral Drug Delivery Devices: Where Do We Stand?

Surveying the landscape of paclitaxel and sirolimus/everolimus devices for peripheral artery disease revascularization, with commentary on advantages and disadvantages and when each might be used, treatment algorithms for above the knee, the next wave of below-the-knee trial data, and the role of bioresorbables.

With Brian DeRubertis, MD; Andrew Holden, MD; Peter A. Schneider, MD; Sabine Steiner, MD; and Edward T.C. Choke, MBBS, FRCS, PhD