The document discusses the STENTYS self-apposing stent and its clinical trials. It summarizes that the stent self-expands to conform to variable vessel sizes, minimizing sizing issues. Clinical trials showed the stent achieved better apposition than balloon-expandable stents, and had low major adverse cardiac event rates. The stent is presented as a solution for treating unusual vessel anatomies like tapering vessels or bifurcations that pose challenges for other stents.

1. JOSE F. DIAZ
JUAN RAMON JIMENEZ UNIVERSITY
HOSPITAL
HUELVA, SPAIN
Self-Apposing® coronary stents:
Do they make a difference?

2. Overdilation
Dissection
Perforation
No
reflow
Malapposition
Underexpansion
Stent
thrombosis Restenosis
3.5 4.5
How important is stent sizing ?

3. Limitations of current stent technology
• Tubular shape does not fully conform to variable
lumen geometry
• Large size differences cannot be accommodated
• Maximum lumen size achieved at implantation
• Size mismatch in primary PCI
• High pressure post dilatation

4. STENTYS Self-Apposing® Stent
Disconnectable
interconnector
DisconnectionDisconnectors
along the stent
• Self-expanding nitinol stent deployed by retracting a sheath (no balloon)
• Bare or Paclitaxel-eluting with biostable polymer
• 6 French, single-wire, rapid exchange
• Disconnecting struts for side-branch access

5. Stent Strut
5 – 8 µm
Abluminal
Polymer
Polysulfone, well proven hemocompatible,
non inflammatory, and non thrombogenic
also used in dialysis and bone replacement
indications
Excipient
Polyvinylpyrrolidone
(PVP) originally used as
blood plasma substitute
2 – 5 µm
Drug
Sirolimus, mixed into the
polymer with the excipient
(1.4µg/mm²), is then
released as excipient
dissolves
Upon activation the Polymer forms a smooth non
thrombogenic surface and remains biostable
Sirolimus Elution from a biostable polymer

6. Technical Specifications
1. Data held on file.
Radial Force Foreshortening Recoil
Cell Area

7. Size selection
* At the vessel size boundaries, it is recommended to choose the smaller size.
Size
Length in
vessel (mm)
Indicated Vessel
Diameter
Maximum
Vessel
Diameter
Side-Branch
Diameter (mm)
Small
17
~2.5 to 3.0mm 4.0mm >2.2022
27
Medium
17
~3.0 to 3.5mm 5.0mm >2.2522
27
Large
17
~3.5 to 4.5mm 6.0mm >2.5022
27

8. STENTYS stent designed for perfect apposition in
coronary anatomies with diameter discrepancy
Smaller Diameter
(tapering)
Enlarged Diameter
(aneurysm)

9. Large vessels
CE Mark indications
Ectatic vesselsBy-pass grafts Tapering vessels
BifurcationAcute Coronary Syndrome
New indications
Currently under “Investigational Device Exemption” trial in the United States
Not for sale in the United States

10. Primary angioplasty (anterior MI)
58 year-old male
smoker, hypertensive

11. Thrombus-containing
lesion

12. 12
LM
LAD

13. 13
thrombectomy
Thrombus unchanged

14. 4.5-3.5x27 self-expanding DES

15. 3x15 NC balloon
4x15 NC balloon

16. result

17. LAD
LM
Perfect apposition

18. LAD
CX

19. CX
LM

20. STENTYS Clinical Program
APPOSITION (STEMI)
I
Feasibility trial: Single Arm – STENTYS BMS (N=25)
 3 day and 6 month QCA and IVUS
II
Randomized trial: STENTYS BMS vs ABBOTT VISION/Medtronic Driver (N=80)
 3 day QCA and OCT, 6 month clinical
III
“Real life” study: Single arm – STENTYS BMS & DES (N=1000)
 30 day and 12, 24 month MACE
IV
Randomized trial: STENTYS Sirolimus DES(S) vs Medtronic Resolute (N=150)
 4 or 9 month OCT
V
IDE - Randomized trial: STENTYS BMS vs ABBOTT Multi-link (N=880)
 12 month TVF, IVUS/OCT sub-study – ENROLLMENT IN PROGRESS
OPEN (Bifurcation)
I
Feasibility trial: Single Arm – STENTYS BMS & DES (N=60)
 6 month QCA and IVUS
II
“Real life” study: Single Arm – STENTYS DES (N=200)
 6 month MACE, OCT sub-group
ADEPT (SVG)
SVG
Randomized trial: STENTYS BMS vs STENTYS DES (N=80)
 6 months QCA – late loss – ENROLLMENT IN PROGRESS
All-comers
SIZING
All-comers registry: STENTYS BMS & DES in ACS (STEMI, NSTEMI) and stable patients
(bifurcation, ectatic, tapered, aneurysm, SVG) (N=3000) – ENROLLMENT IN PROGRESS

21. STEMI program

22. APPOSITION I
• DESIGN: Prospective, non-randomized,
single-arm, multi-center feasibility study
• OBJECTIVE: To evaluate the safety and
efficacy of the STENTYS® stent in AMI
• ENDPOINTS:
– Stent apposition and expansion at 3 days
– MACE at discharge and at 30 days
Independent monitoring: Medpass
Core lab: Cardialysis
Statistical analysis: INSERM U970 (Paris);
Prof. J.P. Tijssen (Amsterdam)
25 patients enrolled between March 2009 and
October 2009 in 5 European clinical sites
25 patients with STENTYS® stent
Angiographic and IVUS
follow-up at 6 months
IVUS at 0 and 3 days
Clinical follow-up at 30 days
Post-PCI IVUS image of a
STENTYS stent in AMI patient
IVUS image 3 days after
procedure in this patient: 19%
increase in reference lumen area
Results: IVUS at baseline and 3 days
Mean Reference area (distal) (mm²) +19%
Mean Stent area (mm²) +18%
Mean Lumen area (mm²) +17%
Minimum Lumen area (mm²) +19%
p<0.02
G. Amoroso et al. EuroIntervention 2011;7:428-436

23. • DESIGN: International, prospective,
randomized, two-arm multi-center trial
• OBJECTIVE: To compare the STENTYS®
Stent with balloon-expandable stents in AMI
• ENDPOINTS:
‒ Stent strut apposition and expansion at 3
days (measured by OCT)
‒ MACE @30 days and 6 months
Independent monitoring: Genae
Core Lab: Cardialysis
80 STEMI patients enrolled between 12/09
and 06/10 in 9 European sites
STENTYS® stent
Clinical follow-up at 30 days
and 6 months
Invasive follow-up at
3 days (QCA, OCT)
VISION / Driver
Balloon-expandable Stent - Day 3 STENTYS® Stent – Day 3
APPOSITION II
0%
28%
0%
10%
20%
30%
STENTYS
Control
p<0.001
Patients with Stent Malapposition
J Am Coll Cardiol Intv. 2012;5(12):1209-1219

24. APPOSITION III
24
• DESIGN: Prospective, non-randomized, single-
arm, multi-center study
• OBJECTIVE: Evaluate safety and performance of
the STENTYS stent in routine clinical practice in
1000 STEMI patients
• ENDPOINTS:
‒ MACE at 1, 12 and 24 months
(MACE defined as cardiac death, target vessel re-MI,
emergent CABG, or clinically-driven TVR)
1000 patients enrolled between
Jun 2010 and Feb 2012
at 50 European sites
Clinical FU in-hospital
and at 1 month
Clinical FU at
1 and 2 years
30 day results presented at PCR 2012 by G. Amoroso
1 year results presented at ACC.13 by G. Montalescot
Hierarchical MACE 30 days 1 year
Death 1.2% 2.0%
Re-AMI 1.0% 1.2%
Clinically driven TLR 1.3% 6.1%
Total 3.5% 9.3%

25. APPOSITION III: Comparative Studies
25
Cardiac Death at 1 year
Pooled analysis conducted by the ACTION Study Group on the most recent studies representing
19,767 patients since 2006
3.9%
2.0%
0%
1%
2%
3%
4%
5%
6%
7%

26. Importance of Post-Dilation
26
APPOSITION III – 1 year results
Post-dilation: yes vs no
Cardiac death or TV-MI
Kaplan-Meier curves

27. • DESIGN: Prospective, randomized, two-arm,
multi-center study
• OBJECTIVE: To compare the endothelization of
the STENTYS SES with a balloon-expandable
DES in AMI
• ENDPOINTS:
• Late malapposition (9 months)
• Strut coverage @ 4 and 9 months
• MACE up to 12 months
150 STEMI patients
STENTYS
Sirolimus
OCT & QCA at
4 months
Clinical FU at 12
months
OCT & QCA
at 9 months
APPOSITION IV
27
Balloon Expandable Stent – 4 m STENTYS Stent – 4 m
31.6%
3.8%
0.0%
20.0%
40.0% STENTYS
Resolute
P=0.03
Stents with all covered struts at 4 months
MEDTRONIC
Resolute

28. • DESIGN: Prospective, randomized, two-
arm, multi-center study
(FDA-approved IDE study)
• OBJECTIVE: To prove the non-inferiority of
the STENTYS BMS compared to the Abbott
Multi-link Vision stent in STEMI patients
• PRIMARY ENDPOINT:
‒ TVF at 12 months
• SECONDARY ENDPOINT:
‒ Acute Stent Apposition (IVUS sub-study)
• PRINCIPAL INVESTIGATORS:
- Maurice Buchbinder and Roxana Mehran
• STEERING COMMITTEE:
‒ M.Buchbinder, D.Cutlip, M.Leon, R.Mehran,
A.Yeung, K.Koch, G. Montalescot, R.J. van
Geuns
880 STEMI patients in ~60 international sites
in US and worldwide
STENTYS
BMS
IVUS/OCT
substudy
(120 patients)
Clinical FU at
12 months
Abbott
Multi-link Vision
Clinical FU at
30 days
APPOSITION V - STEMI
Enrollment terminated

29. Outside of STEMI

30. Disconnection Technology
2. Inflate balloon at low pressure
4. Wide opening to side branch
1. Wire and balloon through struts
3. Bridges disconnect

31. Open I
33
• DESIGN: Prospective, non-randomized, single-arm,
multi-center trial
• OBJECTIVE: To evaluate the safety and feasibility of
the STENTYS DES and BMS in bifurcated lesions
• ENDPOINTS:
• Procedural success
• MACE @ 30 days and 6 months
• Events adjudicated by CEC
• Independent monitoring: Medpass
• Core lab: Cardialysis
63 patients enrolled between September 2007 and
August 2009 in 9 European clinical sites
60 patients with STENTYS stent:
33 patients with STENTYS BMS
27 patients with STENTYS DES
Angiographic and IVUS follow-
up at 6 months
Clinical follow-up at 30 days
Clinical follow-up at 3 months
Baseline angiogram
Angiogram after treatment
of bifurcation lesion
6-month follow-up
angiogram
Results (Number of MACE after 6
months)
DES
Cardiac Death 0
Q-wave Myocardial Infarction 0
Non-Q-wave Myocardial
Infarction
0
Clinically driven TLR 1
S. Verheye et al. EuroIntervention 2011;7:580-587
3 patients not stented

32. Open II
34
• DESIGN: Prospective, non-randomized, single-arm,
multi-center trial
• OBJECTIVE: To evaluate the long-term safety and
efficacy of the STENTYS PES stent in bifurcation
lesions in routine clinical practice.
• Primary Endpoint:
• MACE at 6 months
• Events adjudicated by CEC
• Independent monitoring: IKKF
• Principal Investigators: Dr Naber, Prof. Mudra
217 patients enrolled9 in 21 European clinical sites
4 patients outside
criteria
5 patients not stented
208 patients analyzed
Clinical follow-up at 12 months
Clinical follow-up at 6 months
Results (MACE after 6
months)
Cardiac Death 0.5%
Emergent CABG 0%
Target Vessel MI 4.3%
Clinically driven TLR 5.3%
Total 10.1%
Presented by Dr C. Naber at TCT 2013

35. Predilatation: 2.5x20 mm

39. 3x23 Biolimus DES (overlapping)

45. Prox-LAD

46. Stentys
Septal
Diagonal

47. 2nd-septal

48. overlap

49. Biolimus DES

50. ADEPT - SVG
52
• DESIGN: International, randomized,
prospective, multi-center, two-arm clinical study
• OBJECTIVE: To compare the STENTYS BMS
with the STENTYS DES(P) in Saphenous Vein
Grafts (SVG).
• ENDPOINTS:
‒ In-stent late lumen loss at six months post-
procedure
‒ MACE at 30 days and 6 months
Independent monitoring and Core Lab: Diagram, Zwolle,
The Netherlands
57 SVG patients in 5 EU clinical sites
STENTYS DES(P)STENTYS BMS
QCA at 6 months
OCT sub study
Clinical FU at 1, 6
and 12 monthsEnrollment complete

51. • DESIGN:
International, non-randomized, multi-center, “real-
life” registry on acute and stable patients with a
sizing dilemma.
• OBJECTIVE:
To define self-expanding best practices and to
evaluate the long-term safety and performance of
the STENTYS BMS and DES(P) stents in routine
clinical practice.
• SUBJECT POPULATION:
‒ 3000 patients at 100+ sites.
‒ Indications include: (N)STEMI, Bifurcations,
tapered vessels, SVGs, ectatic vessels, large
vessels, etc.
• ENDPOINTS:
‒ Procedural success
‒ MACE at discharge and at 12-months.
3000 patients, real-life, in
~100 centres worldwide
Clinical follow-up at discharge
Clinical follow-up at
12 months
SIZING – All-comers
Treated with STENTYS BMS
or DES(P)
Patient enrollment in progress

52. CONCLUSIONS
 Self-apposing stents help minimizing the
problem of vessel sizing
 Apposition is better compared to any other
balloon-expandable stent
 The rate of MACE is low
 It is the perfect solution for “unusual”
anatomies