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

2. 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.

3. 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

4. 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

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

6. 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

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

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

9. Implant Procedure

10. Valve Insertion

11. Valve Orientation

12. Anatomically Correct Positioning

13. Valve Deployment

14. Final Result

15. Other patients

16. 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, Filed

17. 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

18. 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, Filed

19. 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: NCT

20. 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

21. 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.

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

23. 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

24. THANK YOU