1. Tendyne Design Features and Clinical Update
Neil Moat
Royal Brompton Hospital, London, UK

2. Disclosure Statement of Financial Interest
Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.
Affiliation/Financial Relationship
inancial Relationship
Company
Consulting Fees/Honoraria
Medtronic, Abbott, Direct Flow Medical, Edwards

3. Tendyne Transcatheter Mitral Valve
Self-Expanding Nitinol Double Frame
Symmetrical Tri-Leaflet Porcine Pericardial Valve
Large Valve Size Matrix
Single inner valve size
Multiple outer frame sizes
Large Effective Orifice Area
Valve Tether to Apex
Adjustable tension provides valve stability
Apical Pad assists in access closure

4. Choice of Valve Dimensions
Item
SL (mm)
SL Oversize
ICD (mm)
ICD Oversize
Perimeter (mm)
Perimeter Oversize
Mitral Dims (CT Imaging) 32 - 41
124
Valve 03 33 4% 40
-1%
125
0.8%
Valve 04 2% 42 6%
133 5%
Valve 05 46
13%
138
11%
End-Systole
Septal-Lateral (SL)
Inter-Commissural Dimension (ICD)

8. Tendyne Proprietary and Confidential
30Mar2016
Tendyne Proprietary and Confidential

9. Gen II Trans-apical Delivery System
Generation II
Generation I
Delivery system with wheel rotation for valve deployment.
Integrated sheath with removable balloon dilator.
Pad positioning tool with wheel mechanisms for tensioning, pin drive, and pad release.
Tower loading eliminates need for bin.
Hand squeeze and zip mechanism for valve deployment.
Separate sheath/dilator.
Pad positioning tool with hand clicks for tether tensioning.
Large sterile bin filled with 20L of saline for valve loading.

11. Tendyne Experience (up to 12 June 2016)
Royal Brompton Hospital, UK
St Vincent’s Hospital, Sydney
Abbott Northwestern, Minneapolis
Prince Charles Hospital, Brisbane
Baylor Heart and Vascular, Dallas
Northshore Hospital, Chicago
Oslo University Hospital, Oslo
37 cases total
32 Early Feasibility Study Implants
5 Compassionate Use Implants (UK)

12. Tendyne Early Feasibility Study
Inclusion criteria:
Severe mitral valve regurgitation of primary or secondary etiology
NYHA functional class II, III or ambulatory IV
Age >18yrs, able to provide informed consent
High risk for cardiac surgery as determined by the Heart team (including Cardiologist and Cardiac Surgeon)
Not ideal candidate for other transcatheter valve interventions
Exclusion criteria:
Severe mitral annular or valvular calcification/stenosis, vegetation or mass
Largest annular dimension >45mm, LVEDD >70mm
LVEF<30%, severe TR/RV dysfunction/pulmonary HT
Prior aortic or mitral valve surgery
Small neo-LVOT (echo, CT modeling, 3D printing)

13. Tendyne EFS: Demographics (n=23) (courtesy of D Muller)
Age (Mean+SD)
years
Age Range
years
Gender
Male
21 (91.3%)
Female
2 (8.7%)
NYHA Functional Class II
11 (47.8%)
III
12 (52.2%) IV
0 (0%)
STS Score (Mean+SD)
( )

14. Tendyne TMVI: Demographics
Variable
Co-morbidities
N=23
Diabetes (all T2DM)
9 (39.1%)
Chronic lung disease/COPD
Chronic kidney disease (eGFR<60)
13 (56.5%)
Prior CVA
1 (4.3%)
Prior thoracotomy
CABG
10 (43.5%)
Prior valve intervention/surgery
0 (0.0%)
Arrhythmia
Atrial fibrillation
Ventricular tachy/fibrillation
0 (0%)
ICD/BiV PPM in situ

15. Tendyne TMVI: Patient Overview
Variable
Mitral Valve pathology
N=22
Primary MR
3 (13.6%)
Secondary MR
15 (68.2%)
Mixed pathology
4 (18.2%)
Previous MV surgery
0 (0%)
Baseline LV function
N=20
LVEF <30%
3 (15%)
LVEF 30-50%
10 (50%)
LVEF >50%
7 (35%)
LVEDD (mm)
mm (53-70)

16. Tendyne TMVI: Procedural Outcomes
Variable
Outcome
N=23
Death
0 (0%)
CVA/MI
Mechanical support
0 (%)
Device-related
Device displacement/embolization
LVOT obstruction
1 (4.3%) – device retrieved
Residual MR
Residual MR/paravalvular leak
Major bleeding
Transfusion
1 (4.3%)

17. Tendyne TMVI: D30 Outcomes
Variable
Outcome
N=23
Death
Cardiac
0 (0%)
Non-cardiac (D13 sepsis)
1 (4.3%)
CVA/MI
MV surgery
Re-hospitalisation
Heart failure*
Pleural effusion
Other (ileus)
Device failure

18. Tendyne TMVI: D30 Echo Outcomes
Variable
LV function
N=20
LVEF <30%
3 (15.0%)
LVEF 30-50%
14 (70.0%)
LVEF >50%
LVEDD (mm)
62+6mm (53-77)
MR Grade
None
15 (78.9%)
Trivial
4 (21.1%)
1-2+
0 (0%)
3-4+

19. Royal Brompton Compassionate Use Experience
PATIENT 1
PATIENT 2
PATIENT 3
PATIENT 4
Age 68 75 87
NYHA
III/IV IV
III
Gender
Female
Male
Prior CABG + -
Prior MV repair
Heart failure hospital adm last 6 months 2 1
Aetiology
Secondary FMR
Primary DMR
PA pressure
105 61 45 TR 3+ 2+ 3

21. TMVI in place: LVOTO & SAM

22. TMVI in place: SAM
TMVI in place: SAM

24. LVOT stenting

25. 6 Minute Walk Test

26. Tricuspid Regurgitation
TR GRADE

27. Pulmonary Arterial Pressure (SYSTOLIC)

28. Royal Brompton Compassionate Use Experience
At 6 months (N=5) – all showed improved 6MWT and a reduction in TR and PAP
At 18 months (N=3) – sustained improvement, no device migration, instability or dysfunction
No late development of new PVL
1 death at 9 months

29. Tendyne TMVI - Summary Fully retrievable, repositionable device
Predictable, controlled deployment
Well tolerated haemodynamically
Effective at reducing MR to nil in vast majority of patients
Apical pad provides stability and aids access site closure
Valve is stable post-deployment (out to 18 months in CU study)
No evidence of late (new) paravalvar leaks
Expanded Global Trial currently enrolling