Conflict of Interest Statement Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Physician Name L Garcia Company/Relationship BostonScientific AdBoard (modest) EV3 Research/AdBoard(modest) Spectranetics AdBoard (unpaid) Pathway Medical AdBoard (unpaid) AngioSculpt AdBoard (unpaid) Idev Research (modest) Scion Cardiovascular Board of Directors Arsenal Medical Equity shareholder TissueGen Medical Equity shareholder

Lawrence A. Garcia, MD DISCLOSURES Consulting Fees ev3, Inc., Spectranetics, Pathway Medical Technologies, Inc., Boston Scientific Corporation Ownership Interest (Stocks, Stock Options or Other Ownership Interest) Scion Cardio-Vascular, Arsenal Medical, TissueGen, Inc.

Rebuttal: The Gods Must Be Crazy! Lawrence A. Garcia, MD Chief, Section Interventional Cardiology Co-Director, Vascular Medicine Program Director, Interventional Cardiology Fellowship Program St. Elizabeth’s Medical Center Tuft’s University School of Medicine Boston, MA

Infra-inguinal Intervention

Forces Exerted on the SFA Unfavorable anatomy Two bifurcations/articulations Unique vessel forces Diffuse disease High incidence of occlusive disease Extremly complex lesion morphologies Competitive flow via PFA Extension / Contraction 1. Torsion 2. Flexion 4. Compression 3.

Nitinol Self-expanding stenting 2009 at 12 months Here is the unmet need! Resilient Durability Fem-Pac Idev Thunder Absolute Vibrant

So we have heard how these few studies mean we still lack an answer How many times do we need to see the same re-hashed data in a meaningless fashion? We need to re-think and save our money for new directions in infra-inguinal therapy.

ABSOLUTE 2-year Clinically no difference from PTA versus endoprosthesis Although patency benefit still present Walking test in favor of stenting Clinically how did this help?

When was an SFA lesion only 6 cm without calcification? What should we do: First throw out the current thoughts that stenting with current technology in short lesions needs further review Second we rethink the process we are trying to treat No longer should these studies be “cherry-picked” for the best lesions to treat When was an SFA lesion only 6 cm without calcification?

Enough already?! We need to rethink the trial designs An OPC with non-scientific endpoint is unfortunate Goals of 30% restenosis is shameful Clinically PTA alone is equivalent to an endoprosthesis at 2 years suggests the stenting approach of revascularization with the current technology is NOT the answer Let’s agree to challenge ourselves to study clinically and anatomically relevant patient groups we see everyday in our practices to glean real scientific answers!