The Medtronic Ventor EngagerTM TAVI System Hendrik Treede, MD University Heart Center Hamburg

I have no real or apparent conflicts of interest to report. Hendrik Treede, MD I have no real or apparent conflicts of interest to report.

TAVI Experience at UHC Hamburg 12/11 501 patients 360 patients Edwards Sapien stented 58 patients CoreValve stented 1 V-in-V 18 patients Direct Flow stentless 34 patients JenaValve stented 21 patients Symetis Acurate stented 20 patients Medtronic Engager stented 228 TA 17 V-in-V 132 TF

Medtronic EngagerTM TAVI System Self-expanding nitinol frame with self-positioning technology allows for controlled release and accurate positioning Bovine pericardial tissue valve with supra-annular valve function Available in 23mm and 26mm device diameters. 29Fr Delivery system custom-designed for accurate anatomical positioning FIM and Feasability trial completed, CE-Mark trial ongoing

EngagerTM Technology Scalloped Bovine Pericardial leaflets Dedicated commissure posts Arms positioned over native leaflets Self-expanding nitinol frame Polyester Skirt

EngagerTM Technology Improved Handle & DS Ergonomics Soft Tip Valve released True over the wire delivery system providing flexibility for better co-axial positioning Integrated sheath device removing the need for separate introducer Partially repositionable/ recapturable system prior to commissure deployment. Improved Handle & DS Ergonomics Soft Tip

Delivery Access The Engager delivery system is designed for Trans-Apical delivery

ECG Gated Contrast CT / 3 Mensio Planning of Procedure ECG Gated Contrast CT / 3 Mensio LAO 17° LC RC NC Cranial 10°

Implant Procedure

Valve Insertion

Valve Orientation

Anatomically Correct Positioning

Valve Deployment

Final Result

Other patients

The Medtronic Engager™ Story EU Pivotal Study Engager™ Feasibility Study Engager™ Delivery System Redesigned Medtronic Acquires Ventor 2007 2008 2009 2010 2011 Embracer First-in-Man Study Embracer Design Completed US Patent #7,201,772 Filed

Early Clinical Results First in Man Trial (N=30) Feasibility Trial (N=10) Age (years) 83±4 (73-90) 83±4 (76-88) EuroSCORE 23±12 (8-63) 25±14 (15-53) Female gender 83% 80% 23 mm valve 100% 40% 30 day mortality 20% (6/30) 10% (1/10) 6 month survival 51% 90% Incidence of new PPM 10% (3/30) 20% (2/10) Mean gradient (1 month) 13±52 16±53 % with > mild AR (1 month) 10%4 0%5 Overall the results of the Feasibility study are comparative to those of the FIM study even though we are talking about a very small patient pool. We had an average age of 83, with the EuroScore being around 25%. 80% of the patients were females and during the study 2 permanent pacemakers were implanted. The one month mean gradient as measured by Echo in the feasibility was 16. 3 n=7 with MG data 5 n=9 with regurgitation data 2 n=17 with MG data 4 n=4 with regurgitation data

The Medtronic Engager™ Story EU Pivotal Study Engager™ Feasibility Study Engager™ Delivery System Redesigned Medtronic Acquires Ventor 2007 2008 2009 2010 2011 Embracer First-in-Man Study Embracer Design Completed US Patent #7,201,772 Filed

Engager™ European Pivotal Trial Purpose Evaluate safety & clinical performance of Engager trans-apical aortic valve system Design Prospective, non-randomized, single arm, multi-centre Patient Population Patients with symptomatic, severe aortic stenosis at high risk or contra-indicated for open AVR Primary Endpoint All-cause mortality at 30 days post-implantation Sample Size & Scope 150 patients 11 sites in Europe & Israel 5 year follow-up ClinicalTrials.gov identifier: NCT01348438

Clinical Endpoints Primary Endpoint: All-cause mortality at 30 days Secondary Endpoints: Safety Clinical Performance MACCE free survival at 30 days & 6 months MAE at 30 days All cause mortality at 6 months Acute device success Procedural success Hemodynamic metrics at 30 days & 6 months D in NYHA: Baseline - 6 mon D in Distance walked (6 min) D in Quality of Life (EQ5D) Incidence of hospitalizations

Engager™ European Pivotal Trial Participating Study Sites Germany German Heart Center (Munich) R. Lange University Heart Center Hamburg (Hamburg) H. Treede Leipzig University Hospital (Leipzig) F. Mohr Heart & Diabetes Center (Bad Oeynhausen) J. Börgermann Uniklinik Köln Heart Center (Cologne) T. Wahlers Kerckhoff Clinic (Bad Nauheim) T. Walther Klinik für Herzchirurgie (Karlsruhe) H. Posival Switzerland University Hospital Zurich (Zurich) V. Falk (PI) Belgium Cliniques Universitaries Saint-Luc (Brussels) P. Astarci Israel Sheba Medical Center (Tel Hashomer) U. Raanani France Hospital Bichat (Paris) P. Nataf References: 1. Medtronic CoreValve® U.S. Pivotal Trial (Extreme Risk Patients). Version 7.0. Mounds View, MN: Medtronic, Inc. Clinical Research; 2011. 2. Medtronic CoreValve® U.S. Pivotal Trial (High Risk Patients). Version 6.0. Mounds View, MN: Medtronic, Inc. Clinical Research; 2011.

Is there a need for another second generation transapical TAVI device? What are the distinct features of the EngagerTM TAVI system ?

Distinct Advantages of Engager™ Design Fixation of native leaflets and true commissure to commissure alignment ensuring clearance from coronary ostia Supra-annular valve position assures uncompromised valve function even in elliptical annuli Stent Design allows less crimping forces and pericardial thickness equal to surgical valves for maximum durability Venturi Effect for less turbulent and guided bloodflow 29 Fr Ease of use: - simple and intuitive delivery - self orienting - good tactile feedback

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