This document describes the BioFreedom trial, a prospective randomized trial comparing polymer-free Biolimus A9-eluting stents to paclitaxel-eluting stents. The trial found that the polymer-free stents were non-inferior to the paclitaxel stents in preventing late lumen loss at 12 months, meeting the primary endpoint. Late lumen loss was also lower for the polymer-free stents compared to the paclitaxel stents at 12 months. Both stent types showed sustained safety up to 12 months with no stent thromboses. The results provide initial evidence that polymer-free drug coated stents can inhibit neointimal hyperplasia as effectively

1. BioFreedom: A Prospective Randomized Trial of Polymer-Free Biolimus A9-Eluting Stents and Paclitaxel-Eluting Stents in Patients with Coronary Artery DiseaseEberhardGrube, MD, FACC, FSCAIon behalf of the BioFreedom InvestigatorsInternational Heart Center Essen, GermanyHospital A Oswaldo Cruz, Instituto Dante Pazzanese, São Paulo, BrazilStanford University, School of Medicine, Stanford, CA

2. BioFreedom™Selectively micro-structured surface holds drug in abluminal surface structuresHypothesis: Polymer-free drug release via porous-eluting stents may reduce late events caused by polymer stent coatings.Potential advantageAvoid long term late adverse effects that might be attributable to the polymer

3. Improved surface integrity since there is no polymer to be sheared or peeled away from the stent struts

4. Possible shorter need of dual antiplatelet therapyProprietary Highly LipophilicLimus drug

5. BioFreedom standarddose(BFD SD)N=35BioFreedom lowdose(BFD LD)N=36TAXUS® Liberté ®N=36BioFreedom standarddose(BFD SD)N=25BioFreedom lowdose(BFD LD)N=26TAXUS® Liberté ®N=24BioFreedom FIM DesignBioFreedom FIM182 patientsSecond CohortFirst Cohort12 Month Clinical FU 99%12 Month Angio FU107 patients4 Month Angio FU75 patientsAngio FU 92%Angio FU 92%Enrollment PeriodSept 2008 – Jan 2009Enrollment PeriodJan 2009 – Jun 2009

6. BioFreedom FIM Study DesignSymptomatic, ischemic heart diseaseNative coronary artery ≥ 2.25 mm and ≤ 3.0 mmLesion length ≤ 14 mmLesion amenable to percutaneous treatment with DESBioFreedom™Standard Dose 15.6 µg/mmBioFreedom™Low Dose 7.8 µg/mmTaxus® Liberté®Clinical Follow-Up 30 d 4 mo 12 mo 2yr 3yr 4yr 5yr Angio and IVUS Follow-upPrimary Endpoint:In-stent Late Lumen Loss (LL) at 12 months (2nd cohort) Non-Inferiority, margin = 0.24 mmSecondary Endpoints:In-stent Late Lumen Loss (LL) at 4 months (1st cohort)MACE and stent thrombosis rate at 30 days, 4, 12 months, 2, 3, 4 & 5 yrs Clinically-driven TLR, TVR and TVF at 4, 12 months, 2, 3, 4 & 5 yrs In-stent/In-segment binary restenosis at 4 months In-stent/In-segment Minimum Lumen Diameter (MLD) at 4 monthsNeointimal hyperplasia volume at 4 months measured by IVUS Biolimus A9 concentrations pre/post procedure at discharge & 30 daysDAPT recommended for a minimum of 6 months

7. 12 Month Angiographic FUIn-Stent Late Lumen Loss: 2nd CohortPrimary EndpointNon – inferiority P valuesP = 0.001P = 0.21 (mm)N = 31 N = 31N = 35All values are presented as median [IQR] .

8. 12 Month Angiographic FUIn-Stent Late Lumen Loss: 2nd CohortPrimary EndpointSuperiority P valuesP = 0.11P = 0.55 (mm)N = 31N = 31 N = 35 All values are presented as median.

9. 12 MonthMACE (KM Estimates)All Patients (1st + 2nd Cohorts) *Time to first event**In-hospital MI All p values are non significant.Tests were performed for BFD SD vs. Taxus and BFD LD vs. Taxus.

10. Possible, probable or definite stent thrombosis as per ARC Definition.All P values are non significant.Tests were performed for BFD SD vs. Taxus and BFD LD vs. Taxus. 12 Month Stent ThrombosisAll Patients (1st + 2nd Cohorts)