Intravascular Imaging Insights into the Mechanism of Action of Focal Force Balloon Angioplasty

LINC 2015 Global Expert Exchange Forum January 28, 2015 Intravascular Imaging Insights into the Mechanism of Action of Focal Force Balloon Angioplasty Sahil A. Parikh, M.D. Assistant Professor of Medicine Director, Research and Innovation Center Director, Experimental Interventional Cardiology Laboratory Director, Interventional Cardiology Fellowship Program Harrington Heart & Vascular Institute University Hospitals Case Medical Center Case Western Reserve University School of Medicine

Disclosure Speaker name: Sahil A. Parikh, MD I have the following potential conflicts of interest to report: x Consulting: Angioscore/Spectranetics, TriReme, Cordis, St. Jude Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) I do not have any potential conflict of interest

Short Segment Occlusion PTA: Satisfactory Angiographic Result?

OCT of TP Trunk Post PTA Sahil A. Parikh, MD

POBA Mechanism of Action Plaque Sheer Stress Formation Plaque Dissection Plaque Folded Half-way Balloon Inflated Balloon Pre-Inflation During Inflation End of Inflation Inflated Balloon MoA 1: Unfolding expansion results in: Shear stress MoA 2: Uncontrolled expansion results in: Dilatation in path of least resistance MoA 1 + 2 = Vessel Trauma (torsional, radial, longitudinal) Vessel trauma manifests as: Severe dissections Elastic recoil Abrupt closure Today s solution: STENTS

Chocolate Design and MoA Goal: Provide stent-like results without permanent implant Design by TriReme Medical: Unique nitinol constraining structure Shields vessel wall from torsional shear stress caused by balloon unfolding Uniformly distributes longitudinal & circumferential forces Modifies plaque via: Modules : Vessel dilatation without cutting or scoring Grooves : Stress relief, plaque modification Reduces dissections Fast deflation, concentric secondary profile MRK394 rev A Grooves [Modules project beyond constraining structure]

Balloon Effect on Simulated Artery Finite Element Analysis Computer Images PTA Balloon Chocolate Balloon Scoring Balloon Plaque High Stress Plaque High Stress Plaque High Stress Low Stress Low Stress Low Stress FEA simulation shows significantly less vessel trauma vs. alternatives Courtesy: TriReme Medical

BTK Procedural Success No Flow Limiting Dissection Achieved <30% Diameter Stenosis physician visual estimate Freedom from Bail-Out Stenting Dissection Rates N=174 99% (173/174) 94% (163/174) 97% (168/174) Bail-Out Stenting Rates 12% 20% How does this compare? 1% 8% 3% 5% 12% 14% Chocolate BAR Odink, PTA Study Bosiers, PTA Arm Chocolate BAR Schmidt Bosiers, BTK DEB PTA Arm Odink H, van den Berg A, Winkens B. Technical and clinical long-term results of infrapopliteal percutaneous transluminal angioplasty for critical limb ischemia. J Vasc Inter radio. Apr 2012: 23(4):461-467 Schmidt BTK PTA Odink, PTA Study Boisers M, Scheinert D, Peetrs P, Torsello G, Zeller T, Delosse K, Schmidt A, Tosserek J, Vinck E, Schwartz L. Randomized comparison of everolimus-eluting versus bare-metal stents in patients with critical limb ischemia and infrapopliteal arterial occlusive disease. J Vasc Surg Feb 201255(2):390-398 Schmidt A, Piorkowski M, Werner M, Ulrich M, Bausback Y, Braunlich S, Ick H, Schuster J, Botsios S, Kruse H, Varcoe R, Scheinert D. First Experience with Drug-Eluting Balloons in Infrapopliteal Arteries. JACC Sep 2011 58(11): 1105-1109 Schmidt A, Ulrich M, Winkler B, Klaeffling C, Bausback Y, Braunlich S, Botsios S, Kruse H, Varcoe R, Scheinert D. Angiographic Patency and Clinical Outcome After Balloon-Angioplasty for Extensive Infrapopliteal Arterial Disease. Courtesy: Tony Das and Jihad Mustapha, LINC 2014

Plaque Composition Courtesy: Hiram Bezerra, MD and Marco Costa, MD, PhD

Angioplasty of Calcified Lesions: Fracture Courtesy: Hiram Bezerra, MD and Marco Costa, MD, PhD No Fracture: Dissection Partial Calcium Fracture Complete Calcium Fracture

Case Example: Lipid Rich Plaque with Medial Calcification

Treatment with Chocolate 4.0x40mm

Localized Dissection without Extension

Case Example: Calcified Lesion

Case Example: Fibrotic LesionAnastomosis

Numerous Examples

CONCLUSIONS Focal Force Balloons have a unique mechanism of action compared to conventional PTA balloons These devices demonstrate good acute performance in ATK and BTK lesions when looking at registry data in a representative group of patients Heterogenous lesion composition confounds our ability to identify specific lesion types which may be particularly well-suited to treatment with these devices Imaging analysis suggests less intimal disruption Chocolate OCT: ClinicalTrials.Gov: NCT02237066