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INTERNATIONAL CAUTION: For distribution only in markets where Engager has been approved. Not approved in the USA, Canada, or Japan. Medtronic Engager Transcatheter.

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Presentation on theme: "INTERNATIONAL CAUTION: For distribution only in markets where Engager has been approved. Not approved in the USA, Canada, or Japan. Medtronic Engager Transcatheter."— Presentation transcript:

1 INTERNATIONAL CAUTION: For distribution only in markets where Engager has been approved. Not approved in the USA, Canada, or Japan. Medtronic Engager Transcatheter Aortic Valve Implantation System UC a EE

2 Device positioning is one of the most significant challenges in TAVI Positioning-related complications reduce hemodynamic improvement and may result in catastrophic clinical outcomes. 1,2,3 Current TAVI Clinical Challenges 1.Gul M, Erkanli K, Kemal Ero M. “Ventricular Embolization of Edwards SAPIEN Prosthesis Following Transcatheter Aortic Valve Implantation.” J Invasive Cardiol 2012: 24(10): Toggweiler S, Wood D, Rodes-Cabau J, et. al. “Transcatehter Valve-in-Valve Implantation for Failed Ballon-Expandable Transcather Aortic Valves.” J Am Coll Cardiol Intv. May 2012,5(5): Pasic M, Buz S, Dreysse S, et. al. “Transapical Aortic Valve Implantation in 194 Patients: problems, complications, and solutions. Ann Thorac Surg. 2010;90:1463–9 Valve Embolization 1 Annular Rupture 3 Coronary Occlusion 3 Paravalvular Leak 2 Positioning-Related Complications

3 Engager provides tactile control during deployment Results from the CE Pivotal Trial demonstrate that Engager’s unique design delivers simple, stable, and repeatable valve positioning 1,2 Engager Simplifies Valve Positioning Paravalvular Leak Paravalvular Leak Valve Embolization Coronary Occlusion Annular Rupture Control Arms provide tactile control and secure the valve during deployment- Engager seals the annulus by capturing the native leaflets with the control arms and conforming to the anatomy with the self-expanding frame Fixation of the native leaflets and true commisure-to- commisure alignment provides clearance for the coronary ostia. Self-expanding frame conforms to varying annular shapes 1.Treede H, Baldus S, Linke A et al. “The Engager transapical aortic valve implantation system: first results from the multi-center European pivotal trial. Presented at EACTS October 29, Holzhey D, Treede H, Bleiziffer S et. al. “Thirty-day Outcomes from the Multi-Centre European Pivotal Trial for Transapical Transcatheter Aortic Valve Implantation with a Self-Expanding Prosthesis.” Presented at EuroPCR May

4 Moderate and severe PVL have been associated with increased mortality with other transcatheter aortic valve systems. 1,2 Patients with moderate or severe PVL at 30 days: –Engager: 0% 3 –Sapien XT: 24.2% 4 Engager has Minimal PVL 1.Kodali et. al. “Two-Year Outcomes after Transcatheter or Surgical Aortic-Valve Replacement.” NEJM : Linke A, et. al. “Meedtronic CoreValve ADVANCE Study.” Presented at TCT Holzhey D, Treede H, Bleiziffer S et. al. “Thirty-day Outcomes from the Multi-Centre European Pivotal Trial for Transapical Transcatheter Aortic Valve Implantation with a Self-Expanding Prosthesis.” Presented at EuroPCR May Leon M, et. al. “A Randomized Evaluation of the SAPIEN XT Transcatheter Valve System in Patients with Aortic Stenosis Who Are Not Candidates for Surgery: PARTNER II, Inoperable Cohort.” Presented at ACC, March 10, 2013.

5 Engager Valve Design Control arms Self-expanding nitinol frame and polyester skirt Supra-annular valve function Bovine pericardial tissue

6 Tactile control during deployment 29 Fr equivalent TA delivery system Integrated introducer sheath Three step deployment Engager TA Delivery System The outer diameter of the integrated sheath is 10.7 mm

7 Benefits of the Engager System 1 1 Simple and stable valve positioning because the control arms provide tactile feedback and secure the valve during deployment 2 2 Minimal paravalvular leak because the control arms capture the native leaflets and the self-expanding frame conforms to the annulus 3 3 Anatomic alignment provides clearance for the coronary ostia

8 D. Holzhey University of Leipzig Heart Center, Leipzig, Germany H. Treede University Heart Center Hamburg, Hamburg, Germany S. Bleiziffer German Heart Center, Munich, Germany J. Börgermann Herz- und Diabeteszentrum, Bad Oeynhausen, Germany T. Walther Kerckhoff-Klinik, Bad Nauheim, Germany E. Raanani The Sheba Medical Center, Tel Hashomer, Israel J-L. Vanoverschelde Clinique Universitaires Saint Luc, Brussels, Belgium V. Falk University Hospital, Zurich, Switzerland (on behalf of the Engager Investigators)

9 Optimal TAVI requires accurate valve positioning Engager TAVI System Allows anatomically correct rotational positioning of the valve Captures the native leaflets for sealing Is expected to ensure optimal positioning of the valve within the annulus Provides possible reduction of paravalvular regurgitation First report of the complete 30-day patient outcomes for all patients from the Engager European Pivotal Trial Engager | Background

10 Primary Endpoint: All-cause mortality at 30 days 100% of all subjects monitored Assessment by an independent echocardiography core lab All serious adverse events adjudicated by independent Clinical Events Committee Clinical and safety endpoints reported according to Valve Academia Research Consortium (VARC I) definition Engager | Study Overview

11 Germany Leipzig University Hospital (Leipzig)Dr. D. Holzhey / Prof. A. Linke Hamburg University Hospital (Hamburg)Dr. H. Treede / Prof. S. Baldus German Heart Center (Munich)Dr. S. Bleiziffer / Dr. A. Wagner Heart & Diabetes Center (Bad Oeynhausen)Dr. J. Börgermann / Dr. W. Scholtz Kerckhoff Clinic (Bad Nauheim)Dr. T. Walther / Dr. H. Möllmann Switzerland University Hospital Zurich (Zurich)Prof. V. Falk / Dr. R. Corti Belgium Cliniques Universitaires Saint-Luc (Brussels)Prof. J.-L. Vanoverschelde / Dr. P. Astarci Israel Sheba Medical Center (Tel Hashomer)Dr. E. Raanani / Dr. V. Guetta Engager | Pivotal Trial Sites

12 Engager | Subject Disposition

13 Engager CE Pivotal | Baseline Characteristics

14 *124 patients received the Engager bioprosthesis. Engager CE Pivotal | Procedural Results

15 At 30 days, 23 patients could not be included: unable to assess (n=9), death(n=10), withdrawal (n=4). Engager CE Pivotal | Functional Status Percent of Patients

16 *Calculated for all implanted patients (n=124) Engager CE Pivotal | 30-Day Outcomes (N=125)

17 Core lab echocardiograms were reviewed for N=80 patients 8/80 (10%) were unable to be assessed. Engager CE Pivotal | Paravalvular Regurgitation Percent of Patients

18 Displayed as mean ± standard deviation. Engager CE Pivotal | Valve Performance

19 Reported values reflect expert adjudicated evaluations. Calculated for all implanted patients (N=124). Engager CE Pivotal | Pacemaker Implantation

20 The Engager bioprosthesis can be implanted with a high degree of technical success by multiple operators and with an acceptable incidence of serious procedural complications The system restores effective aortic valve hemodynamic performance: it relieves aortic valve stenosis without inducing significant regurgitation The Engager TAVI system performs as intended with an acceptable risk/benefit ratio for patients with symptomatic, severe aortic stenosis who are at high or extreme risk for surgical aortic valve replacement. Engager CE Pivotal | Conclusions

21 INTERNATIONAL CAUTION: For distribution only in markets where Engager has been approved. Not approved in the USA, Canada, or Japan. Engager is a registered trademark of Medtronic, Inc. UC EE


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