The Medtronic Ventor Engager TM TAVI System Hendrik

The Medtronic Ventor Engager. TM TAVI System Hendrik Treede, MD University Heart Center Hamburg

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 Core. Valve stented 1 V-in-V 132 TF 228 TA 17 V-in-V 18 patients Direct Flow stentless 34 patients Jena. Valve stented 21 patients Symetis Acurate stented 20 patients Medtronic Engager stented

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

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

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

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

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

Implant Procedure

Valve Insertion

Valve Orientation

Anatomically Correct Positioning

Valve Deployment

Final Result

Other patients

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

Early Clinical Results First in Man Trial (N=30) Feasibility Trial (N=10) Age (years) 83± 4 (73 -90) 83± 4 (76 -88) Euro. SCORE 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% 10% (3/30) 20% (2/10) Mean gradient (1 month) 13± 52 16± 53 % with > mild AR (1 month) 10%4 0%5 Incidence of new PPM 3 n=7 5 n=9 with regurgitation data 2 4 n=4 with regurgitation data with MG data n=17 with MG data

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

Engager™ European Pivotal Trial Purpose Evaluate safety & clinical performance of Engager trans-apical aortic valve system Design Prospective, non-randomized, single arm, multicentre 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 Clinical. Trials. gov identifier: NCT 01348438

Clinical Endpoints Primary Endpoint: All-cause mortality at 30 days Secondary Endpoints: Safety § MACCE free survival at 30 days & 6 months Clinical Performance § Acute device success § Procedural success § MAE at 30 days § § All cause mortality at 6 months Hemodynamic metrics at 30 days & 6 months § D in NYHA: Baseline - 6 mon § D in Distance walked (6 min) § D in Quality of Life (EQ 5 D) § Incidence of hospitalizations

Engager™ European Pivotal Trial Participating Study Sites • • • Germany • German Heart Center (Munich) • University Heart Center Hamburg (Hamburg) • Leipzig University Hospital (Leipzig) • Heart & Diabetes Center (Bad Oeynhausen) • Uniklinik Köln Heart Center (Cologne) • Kerckhoff Clinic (Bad Nauheim) • Klinik für Herzchirurgie (Karlsruhe) Switzerland • University Hospital Zurich (Zurich) R. Lange H. Treede F. Mohr J. Börgermann T. Wahlers T. Walther H. Posival 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

Is there a need for another second generation transapical TAVI device? What are the distinct features of the Engager. TM 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 • Ease of use: - simple and intuitive delivery - self orienting - good tactile feedback 29 Fr

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