international caution: for distribution only in markets where engager has been approved. not...

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

Medtronic EngagerTranscatheter Aortic Valve Implantation System

UC201305822a EE

• 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):537-538.2. 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):571-

5773. 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

• Engager provides tactile control during deployment• Results from the CE Pivotal Trial demonstrate that Engager’s unique

design delivers simple, stable, and repeatable valve positioning1,2

Engager Simplifies Valve Positioning

ParavalvularLeak

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, 2012.2. 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 21 2013.

• 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 2012. 366:1686-1695.2. Linke A, et. al. “Meedtronic CoreValve ADVANCE Study.” Presented at TCT 20123. 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 21 2013.4. 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.

Engager Valve Design

• Control arms

• Self-expanding nitinol frame and polyester skirt

• Supra-annular valve function

• Bovine pericardial tissue

• 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

Benefits of the Engager System

1Simple and stable valve positioning because the control arms provide tactile feedback and

secure the valve during deployment

2Minimal paravalvular leak because the

control arms capture the native leaflets and the self-expanding frame conforms to the

annulus

3 Anatomic alignment provides clearance for the coronary ostia

Thirty-day Outcomes from the Multi-Centre European Pivotal Trial for Transapical Transcatheter Aortic Valve Implantation with a Self-Expanding Prosthesis

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)

• 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

• 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

• 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

Engager | Subject Disposition

Engager CE Pivotal | Baseline Characteristics

*124 patients received the Engager bioprosthesis.

Engager CE Pivotal | Procedural Results

At 30 days, 23 patients could not be included: unable to assess (n=9), death(n=10), withdrawal (n=4).

Engager CE Pivotal | Functional StatusPe

rcen

t of P

atien

ts

*Calculated for all implanted patients (n=124)

Engager CE Pivotal | 30-Day Outcomes(N=125)

• Core lab echocardiograms were reviewed for N=80 patients• 8/80 (10%) were unable to be assessed.

Engager CE Pivotal | Paravalvular RegurgitationPe

rcen

t of P

atien

ts

Displayed as mean ± standard deviation.

Engager CE Pivotal | Valve Performance

Reported values reflect expert adjudicated evaluations. Calculated for all implanted patients (N=124).

Engager CE Pivotal | Pacemaker Implantation

• 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

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.

UC201305822 EE