Resolute Integrity. Independent Conformability Assessment

Transcription

1 Resolute Integrity Independent Conformability Assessment

2 Stent Conformability and its Clinical Importance Immediate post-deployment stent geometry determines neointimal thickness independently of arterial injury 1 The presence of late incomplete stent apposition (ISA) was significantly associated with the development of thrombus at follow-up detected by OCT. The presence of late ISA and the absence of neointimal hyperplasia could lead to late stent thrombosis 2 The longitudinal straightening effect of coronary artery stents contributes significantly to the occurrence of MACE and angiographic restenosis 3 1 Circulation: Journal of the American Heart Association - Stent and Artery Geometry Determine Intimal Thickening Independent of Arterial Injury - Joseph M. Garasic, MD et. al. 2 European Heart Journal The fate of incomplete stent apposition with drug-eluting stents: an optical coherence tomography-based natural history study Yukio Ozaki et. al. 3 - Journal of the American College of Cardiology - Longitudinal Straightening Effect of Stents Is an Additional Predictor for Major Adverse Cardiac Events. Mariann Gyo ngyo si, MD et. al.

3 Independent Conformability Assessment Finite Element Analysis (FEA) is a tool to virtually predict the unknown structural response of a system by approximating the physical reality Study performed by Dr. Peter Mortier, FEops / Ghent University, Belgium* Study Objectives: Conformability 1. Impact of stent design on strut apposition 2. Vessel wall stress after deployment of stent associated with vessel straightening Simulated lesion used in the study *Manuscript in preparation

4 Comparing Strut Apposition After Stent Implantation in a Stenosed Vessel Strut to Artery Distance (microns) Resolute Integrity DES 150 Xience Prime DES Red indicates a larger distance between stent and artery wall 40 Promus Element DES 0.0 Resolute Integrity DES has better strut apposition as compared to Xience Prime DES and Promus Element DES Note: All stents were deployed in the simulated stenosed vessel at an inflation pressure of 12 atm Simulated FEA studies Resolute Integrity DES (3.0 x 18.0 mm) vs. Abbott Xience Prime DES (3.0 x 18 mm) and Boston Scientific Promus Element DES (3.0 x 16 mm) were performed by Dr. Peter Mortier, FEops / Ghent University-Belgium (Manuscript in preparation). These tests may not be indicative of clinical performance.

5 Comparing Strut Apposition After Stent Implantation in a Stenosed Vessel Percentage of stent struts at a distance larger than 20 micron Resolute Integrity Lower is better Xience Prime Promus Element Percentage of stent struts Resolute Integrity DES has better strut apposition as compared to Xience Prime DES and Promus Element DES Simulated FEA studies Resolute Integrity DES (3.0 x 18 mm) vs. Abbott Xience Prime DES (3.0 x 18 mm) and Boston Scientific Promus Element DES (3.0 x 16 mm) were performed by Dr. Peter Mortier, FEops / Ghent University-Belgium (Manuscript in preparation). These tests may not be indicative of clinical performance.

6 Comparing Vessel Wall Stress After Stent Implantation in a Stenosed Vessel percentile of axial stresses within the intima [kpa] LOWER IS BETTER Resolute Integrity Xience Prime Axial stress [kpa] Lower is better Axial Stress [kpa] Promus Element 0 Resolute Integrity Xience Prime Promus Element Resolute Integrity DES has lower vessel wall stress associated with w longitudinal coronary artery straightening as compared to Xience Prime DES and Promus Element DES Simulated FEA studies Resolute Integrity DES (3.0 x 18 mm) vs. Abbott Xience Prime DES (3.0 x 18 mm) and Boston Scientific Promus Element DES (3.0 x 20 mm) were performed by Dr. Peter Mortier, FEops / Ghent University-Belgium (Manuscript in preparation). These tests may not be indicative of clinical performance.

7 Comparison of Device Performance for Market Leading DES LESION ACCESS Trackability Crossing Profile Pushability PLACEMENT ACCURACY Radiopacity Stent Foreshortening LESION COVERAGE Scaffolding Radial Strength Strut Apposition Resolute Integrity Xience Prime Promus Element Best Middle Worst ANATOMICALLY COMPLEX LESIONS Side Branch Access Vessel Conformability 1 Resolute Integrity DES has better vessel conformability as compared to Xience Prime DES and Promus Element DES Bench test data on file at Medtronic 1 - Simulated FEA studies Integrity Resolute DES vs. Abbott Xience Prime DES and Boston Scientific Promus Element DES were performed by Dr. Peter Mortier, FEops / Ghent University-Belgium (Manuscript in preparation). These tests may not be indicative of clinical performance.

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