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For OMA distribution only. Trademarks may be registered and are the property of their respective owners © 2015 Medtronic, Inc. All Rights Reserved. 10219749DOC_1A.

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Presentation on theme: "For OMA distribution only. Trademarks may be registered and are the property of their respective owners © 2015 Medtronic, Inc. All Rights Reserved. 10219749DOC_1A."— Presentation transcript:

1 For OMA distribution only. Trademarks may be registered and are the property of their respective owners © 2015 Medtronic, Inc. All Rights Reserved. 10219749DOC_1A 10/15 For OMA distribution only. Trademarks may be registered and are the property of their respective owners © 2015 Medtronic, Inc. All Rights Reserved. 10219749DOC_1A 10/15 RevElution Clinical Trial Subjects ( N = 6)123456 20001-00120001-00220001-00320006-00220013-00120013-002 Patient Demographics Age (n) 786570727460 Gender (M/F) FMMMMF Diabetes (Y/N) YYYYNY (ID) Hypertension (Y/N) YYYYYY Hyperlipidemia (Y/N) YYYYYY Prior MI (Y/N) NYNYYN Prior PCI (Y/N) NYNNYY Procedural Characteristics Access Route TR Lesions treated (n) 211111 Diameter stenosis (%)95/907595709590 RVD (mm)3.0/3.53.5 3.02.93.0 Lesion Length (mm)13/810141516 Pre-Dilatation Performed (Y/N)YYYYYY Stents Implanted (n)1/111112 Baseline Demographics Daniel Chamié, MD Interventional Cardiologist, Institute Dante Pazzanese of Cardiology Director, OCT Core Laboratory, Cardiovascular Research Center Sao Paulo, Brazil

2 For OMA distribution only. Trademarks may be registered and are the property of their respective owners © 2015 Medtronic, Inc. All Rights Reserved. 10219749DOC_1A 10/15 For OMA distribution only. Trademarks may be registered and are the property of their respective owners © 2015 Medtronic, Inc. All Rights Reserved. 10219749DOC_1A 10/15 RevElution Clinical Trial OCT Results – Cross Section Level 1 Month Follow Up N = 6 patients N = 7 lesions N = 8 stents Analyzed Stent Length, mm 21.66 ± 9.41 Total number of analyzed cross-sections 258 Cross-Sections Analyzed Per Scaffold 36.86 ± 16.12 Mean reference lumen area, mm 2 7.43 ± 1.69 Mean reference lumen diameter, mm 3.24 ± 0.44 Daniel Chamié, MD Interventional Cardiologist, Institute Dante Pazzanese of Cardiology Director, OCT Core Laboratory, Cardiovascular Research Center Sao Paulo, Brazil

3 For OMA distribution only. Trademarks may be registered and are the property of their respective owners © 2015 Medtronic, Inc. All Rights Reserved. 10219749DOC_1A 10/15 For OMA distribution only. Trademarks may be registered and are the property of their respective owners © 2015 Medtronic, Inc. All Rights Reserved. 10219749DOC_1A 10/15 RevElution Clinical Trial OCT Results – Cross Section Level Stent Analysis Mean Stent Area, mm2 9.07 ± 1.54 8.73 ± 1.68 0.652 Mean stent diameter, mm 3.38 ± 0.293.32 ± 0.310.564 Lumen Analysis Minimum Lumen Area, mm27.22 ± 1.676.62 ± 1.650.389 Incomplete Stent Apposition (ISA) Quantification No. of Lesions with ISA, n (%) 6/6 (100%)4/7 (57.14%) --- Mean ISA Area, mm20.57 ± 0.290.88 ± 0.490.230 Mean ISA Volume, mm33.65 ± 3.963.17 ± 3.390.112 Acute Plaque Prolapse Quantification Plaque Prolapse Area, mm20.27 ± 0.06--- Plaque Prolapse Volume, mm36.22 ± 2.55--- Neointimal Hyperplasia (NIH) Quantification Mean NIH Area, mm2---0.49 ± 0.18--- Mean NIH Volume, mm3---10.86 ± 5.99--- Mean NIH Obstruction, %---5.82 ± 2.18--- Post-Procedure N = 5 patients N = 6 lesions N = 7 stents 1 Month Follow Up N = 6 patients N = 7 lesions N = 8 stentsP-value Daniel Chamié, MD Interventional Cardiologist, Institute Dante Pazzanese of Cardiology Director, OCT Core Laboratory, Cardiovascular Research Center Sao Paulo, Brazil

4 For OMA distribution only. Trademarks may be registered and are the property of their respective owners © 2015 Medtronic, Inc. All Rights Reserved. 10219749DOC_1A 10/15 For OMA distribution only. Trademarks may be registered and are the property of their respective owners © 2015 Medtronic, Inc. All Rights Reserved. 10219749DOC_1A 10/15 OCT Results – Strut level RevElution Clinical Trial Post- Procedure N = 5 patients N = 6 lesions N = 7 stents 1 Month Follow Up N = 6 patients N = 7 lesions N = 8 stentsP-value Total number of analyzed struts 2,8913,099 Frequency of covered struts per lesion, % --- 89.84 ± 5.06 N/A Frequency of malapposed struts per lesion, % 4.85 ± 2.992.03 ± 2.73 0.002 Mean NIH thickness over covered struts, mm --- 0.06 ± 0.02 N/A Daniel Chamié, MD Interventional Cardiologist, Institute Dante Pazzanese of Cardiology Director, OCT Core Laboratory, Cardiovascular Research Center Sao Paulo, Brazil

5 For OMA distribution only. Trademarks may be registered and are the property of their respective owners © 2015 Medtronic, Inc. All Rights Reserved. 10219749DOC_1A 10/15 For OMA distribution only. Trademarks may be registered and are the property of their respective owners © 2015 Medtronic, Inc. All Rights Reserved. 10219749DOC_1A 10/15 RevElution Clinical Trial Daniel Chamié, MD Interventional Cardiologist, Institute Dante Pazzanese of Cardiology Director, OCT Core Laboratory, Cardiovascular Research Center Sao Paulo, Brazil Frequency (%) per lesion OCT Results – 1 Month Follow Up 0.06

6 For OMA distribution only. Trademarks may be registered and are the property of their respective owners © 2015 Medtronic, Inc. All Rights Reserved. 10219749DOC_1A 10/15 For OMA distribution only. Trademarks may be registered and are the property of their respective owners © 2015 Medtronic, Inc. All Rights Reserved. 10219749DOC_1A 10/15 Frequency of Covered Struts Per Lesion RevElution Clinical Trial Daniel Chamié, MD Interventional Cardiologist, Institute Dante Pazzanese of Cardiology Director, OCT Core Laboratory, Cardiovascular Research Center Sao Paulo, Brazil Frequency of Covered Struts per Lesion (%) 1 Circulation. 2007;115:2435-2441 In a stent with 30% uncovered struts (70% covered), the odds ratio for thrombus is 9.0 (95% CI, 3.5 to 22.0) compared with a stent with complete coverage 1 A univariable logistic GEE model of occurrence of thrombus in a stent section versus RUTSS shows that there is a considerable elevation of risk of thrombus as the RUTSS increases. 1 (RUTSS) = variable ratio of uncovered to total struts per section

7 For OMA distribution only. Trademarks may be registered and are the property of their respective owners © 2015 Medtronic, Inc. All Rights Reserved. 10219749DOC_1A 10/15 For OMA distribution only. Trademarks may be registered and are the property of their respective owners © 2015 Medtronic, Inc. All Rights Reserved. 10219749DOC_1A 10/15 Daniel Chamié, MD Interventional Cardiologist, Institute Dante Pazzanese of Cardiology Director, OCT Core Laboratory, Cardiovascular Research Center Sao Paulo, Brazil Case 20001-002 Post-Procedure 1-Month Follow-up 0.6 mm2 mm8 mm 10 mm18 mm Age (n)65 Gender (M/F)M Diabetes (Y/N)Y Hypertension (Y/N)Y Diameter stenosis (%)75 RVD (mm)3.5 Lesion Length (mm)10 Pre-Dilatation Performed (Y/N)Y Stents Implanted (n)1 Smooth circular NIH

8 For OMA distribution only. Trademarks may be registered and are the property of their respective owners © 2015 Medtronic, Inc. All Rights Reserved. 10219749DOC_1A 10/15 For OMA distribution only. Trademarks may be registered and are the property of their respective owners © 2015 Medtronic, Inc. All Rights Reserved. 10219749DOC_1A 10/15 Post-Procedure 1-Month Follow-up 0.6 mm14 mm17 mm 17.8 mm42.2 mm Case 20013-002 Diameter stenosis (%)90 RVD (mm)3.0 Lesion Length (mm)16 Pre-Dilatation Performed (Y/N)Y Stents Implanted (n)2 Age (n)60 Gender (M/F)F Diabetes (Y/N)Y (ID) Hypertension (Y/N)Y Daniel Chamié, MD Interventional Cardiologist, Institute Dante Pazzanese of Cardiology Director, OCT Core Laboratory, Cardiovascular Research Center Sao Paulo, Brazil

9 For OMA distribution only. Trademarks may be registered and are the property of their respective owners © 2015 Medtronic, Inc. All Rights Reserved. 10219749DOC_1A 10/15 For OMA distribution only. Trademarks may be registered and are the property of their respective owners © 2015 Medtronic, Inc. All Rights Reserved. 10219749DOC_1A 10/15 Early (1M) Healing of Overlapping Struts Case 20013-002 Daniel Chamié, MD Interventional Cardiologist, Institute Dante Pazzanese of Cardiology Director, OCT Core Laboratory, Cardiovascular Research Center Sao Paulo, Brazil

10 For OMA distribution only. Trademarks may be registered and are the property of their respective owners © 2015 Medtronic, Inc. All Rights Reserved. 10219749DOC_1A 10/15 For OMA distribution only. Trademarks may be registered and are the property of their respective owners © 2015 Medtronic, Inc. All Rights Reserved. 10219749DOC_1A 10/15 RevElution Clinical Trial The 1M OCT data from the RevElution Clinical Trial (N = 6 patients; 8 stents) demonstrates an early healing profile with high rates of strut coverage of approx. 90% at 1 month. Additionally, the data also show a high efficacy profile as attested by low NIH formation. –The low malapposition seen post-procedure was effectively halved within 1 month giving evidence to rapid healing –At 1 M the NIH area was 0.49 mm 2, percent obstruction 5.82% and NIH thickness: 0.06mm Additional datasets at later timepoints will provide valuable information to further confirm these early results. Conclusions

11 For OMA distribution only. Trademarks may be registered and are the property of their respective owners © 2015 Medtronic, Inc. All Rights Reserved. 10219749DOC_1A 10/15 For OMA distribution only. Trademarks may be registered and are the property of their respective owners © 2015 Medtronic, Inc. All Rights Reserved. 10219749DOC_1A 10/15 Authors: Stephen G Worthley, Alexandre Abizaid, Ajay J Kirtane, Daniel Simon, Stephan Windecker, Gregg W Stone Institution(s): The University of Adelaide, Adelaide, Australia, Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil, Columbia University / Cardiovascular Research Foundation, New York, NY, Case Western Reserve University School of Medicine, Cleveland, United States, Bern University Hospital, Bern, Switzerland, Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY Abstract Background: The novel drug filled coronary stent (DFS; Medtronic, Inc., Santa Rosa, CA) is formed from a continuous tri-layered wire with the innermost layer removed to create a hollow strut lumen that functions as an internal drug reservoir. Small holes (~20 μm) are laser drilled into the abluminal side of the stent, and the internal chamber is loaded with sirolimus. The DFS provides controlled drug elution from an internally loaded drug platform without utilization of a polymeric matrix, and thus may avoid chronic inflammation and adverse vascular responses associated with stents using polymer based drug release. A porcine coronary model demonstrated complete stent strut coverage at 28 days without inflammation. Clinical outcomes in humans with this device have not yet been assessed. Methods: The Clinical Evaluation of the Medtronic Polymer Free Drug Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions: REVascularization using a nonpolymeric drug ELUTing stent with Internal drug lOadiNg (RevElution Trial) is a first in human prospective, multicenter, nonrandomized study of the DFS. Approximately 100 subjects will be enrolled at 15 international sites and followed through 5 years. Subjects with de novo lesions (single lesion or two lesions in separate target vessels) in native coronary arteries with a reference vessel between 2.25 and 3.50 mm in diameter will be treated with the DFS. Baseline optical coherence tomography (OCT) will be performed, and subjects will be assigned based on sequence of enrollment into cohorts with different durations of paired OCT follow up at 1, 2, 3, and 6 months post implantation (15 subjects in each), as well as at 9 and 24 months (30 subjects in each). In addition to serial OCT imaging, other standard clinical and angiographic/IVUS parameters will also be assessed. Results: Results and Conclusions: The DFS is designed to provide controlled release of sirolimus through an internally loaded drug platform, thus eliminating the need for a polymeric matrix. RevElution is the first study to assess the vascular responses, efficacy, and safety of this novel device. One month OCT outcomes from the RevElution study will be reported at TCT 2015, providing an early assessment of neointimal coverage and stent apposition after DFS implantation.

12 For OMA distribution only. Trademarks may be registered and are the property of their respective owners © 2015 Medtronic, Inc. All Rights Reserved. 10219749DOC_1A 10/15 For OMA distribution only. Trademarks may be registered and are the property of their respective owners © 2015 Medtronic, Inc. All Rights Reserved. 10219749DOC_1A 10/15 Case 20013-002 40.80 mm Early Healing of Overlapping Struts Post-Procedure 1-Month Follow-up Post-Procedure 1-Month Follow-up OLP 3.2 mm Post-Procedure 1-Month Follow-up Daniel Chamié, MD Interventional Cardiologist, Institute Dante Pazzanese of Cardiology Director, OCT Core Laboratory, Cardiovascular Research Center Sao Paulo, Brazil


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