Largest Bi furcat ion Randomized Cl inical Tr ial enrol led 704 pat ients in 12 countries and 58 sites.

1st Powered Randomized Cl inical Tr ial to Evaluate a Dedicated Bifurcation Stent

1st Bi furcat ion Study with Angiographic 3D Analysis

1st Bi furcat ion Study with IVUS Core Lab Analysis

ENROLLMENT BETWEEN DECEMBER 2010 AND NOVEMBER 2012

PATIENT FLOWRandomized

N=704

Tryton + DESN=355

Angiographic N=326

Tryton= 158 Provisional= 168

IVUS

N=94Tryton= 59

Provisional= 35

Tryton4= Lost to F/U2= Patient withdrawal4= Death

Provisional6= Lost to F/U5= Patient withdrawal4= Death

Provisional + DESN=349

Clinical FU at 9 months = 97%Angiographic FU at 9 months = 87%

9 Month Follow-up

N=681Tryton = 345

Provisional = 336

Tryton IDE StudyTr y ton shows lower target vessel failure rates and superior percentage diameter stenosis in

the intended patient population.

IDE investigators comment on clinical outcomes

A Randomized Comparison of the Tryton Side-Branch Bifurcation Stent vs. a Provisional Stent Strategy in True Coronary Bifurcation Lesions

TOTAL POPULATION (9 MONTHS FOLLOW-UP)

TVF: Non-inferiority not met% Diameter Stenosis: Tryton superior to provisional (P = 0.002)Main Branch Stent: Efficacy unaffectedNo cardiac death, low TVR, low clinically relevant MI

PRIMARY ENDPOINT TARGET VESSEL FAILURE

SECONDARY ENDPOINT SIDE BRANCH %DS (IN-SEGMENT)

SUMMARY FOR THE ENTIRE PATIENT COHORT:

Tryton

Spontaneous

Tryton

Provisional

Provisional

0

0

5

10

10

20

15

30

20

50

40

%

%

TVF

% DIAMETER STENOSIS

12.8

38.6

0 0

10.7

3.6

17.4

31.6

15.1

4.7

P=0.108

P=0.002

P=0.109

P=0.564

“The Tryton two stent strategy in true bifurcations compared with the provisional strategy (side branch stents) did not meet the non-inferiority clinical endpoint (TVF), due to a relatively higher frequency of small peri-procedural CK-MB elevations.”

“Tryton improved the side branch % diameter stenosis at FU (P=0.002) and the DES in the main vessel performed well in both arms.”

[M.B. Leon TCT 2013]

“90% of the Target Vessel Failure in the Tryton arm were peri-procedural Myocardial Infarctions (MI) with only 1.5% of spontaneous MI.”

[M.B. Leon TCT 2013]Cardiac Death Target Vessel MI Clinically Driven TVR

N O N H I E R A R C H I C A L

0.9 1.5

>90% MIs peri-procedural

Primary Non-Inferiority Endpoint Not Met

Secondary Endpoint Superiority Met

IDE INVESTIGATOR COMMENTS: “From scientific point of view, non-spontaneous MI are important, because they tell us about something related to the procedure (more re-wiring, pre- and post-dilatations, longer time of procedures etc). Nevertheless the clinical relevance and the influence on patients prognosis is minor if any, depending on the degree of the CKMB elevation”

IDE INVESTIGATOR COMMENTS: “One of the limitations of the different techniques used so far with a two-stent strategy is to jeopardize the acute result in the main vessel in order to treat the side branch. This may have important implications in terms of stent thrombosis and restenosis”

IDE INVESTIGATOR COMMENTS: “We are using the Tryton stent since several years ago and we believe that it provides an easy, safe, effective and predictable treatment of complex bifurcation lesions”

IDE INVESTIGATOR COMMENTS: “We often see moderate CK-MB rise after treatment of complex bifurcation lesions with a two stent strategy. In our series this did not have any detrimental effect on long-term outcome”

A Randomized Comparison of the Tryton Side-Branch Bifurcation Stent vs. a Provisional Stent Strategy in True Coronary Bifurcation Lesions

Post-hoc Analysis of the Intended Study Population:Justification - Protocol inclusion criteria mandated side branches of ≥2.5mm by visual estimate, equivalent to ≥2.25 mm by core lab QCA

INTENDED POPULATION: SIDE BRANCH RVD ≥2.25MM (9 MONTHS FOLLOW-UP)

TARGET VESSEL FAILURE

ANGIOGRAPHIC OUTCOMES

SUMMARY FOR ≥2.25mm REFERENCE VESSEL DIAMETER COHORT:

Tryton N=146

Tryton N=64

Provisional N= 143

Provisional N= 81

0

0

8

20

6

15

4

10

2

5

12

30

10

25

14

35

18

45

16

40

%

%

TVF

15.6

40.6

32.1

0 0

12.1

4.3

11.39.2

3.5

P=0.383

P=0.563

P=0.004

P=0.260

P=0.769

“It’s difficult to enroll complex “high-risk” bifurcation lesions in clinical trials (only 41% had side branches ≥ 2.25 mm)”.

[M.B. Leon TCT 2013]Cardiac Death

SB % Diameter Stenosis SB Binary Restenosis

Target Vessel MI Clinically Driven TVR

N O N H I E R A R C H I C A L

17/141 6/13922/141

81 63 26/81 14/63

13/141 5/14116/141

30.4

22.2

TVF drastically reduced by >25% for intended population cohort: % Diameter Stenosis: Tryton superior to provisional (P = 0.004) Main Branch Stent: Efficacy unaffectedNo cardiac death, low TVR, low clinically relevant MI

>25% reduction in SB% diameter stenosis and > 30% reduction SB binary stenosis

IDE INVESTIGATOR COMMENTS: “Small vessels are unlikely to do well with a stent. Large complex lesions are most likely to benefit from technology that is effective - particularly as balloon trauma to a large side branch is potentially clinically important”

IDE INVESTIGATOR COMMENTS: “I have much experience with this device, and have been using it for years. All the patients were followed clinically, many of them angiographically. The early and long-term results have always been surprisingly good.”

IDE INVESTIGATOR COMMENTS:

“As an operator familiar with the Tryton I am satisfied with this data.”

The Tryton Clinical Outcomes versus Provisional Trials Clinical Data from RCT with Follow-up from 6 to 12 Months

TRYTON CLINICAL TVF RATES COMPARE FAVORABLY WITH HISTORICAL DATA

0

5

10

15

20

%

I-BIGIS12 months

BIFURCATIONS in stent

9 months

META-ANALYSIS1 stent

10 months

META-ANALYSIS2 stent

10 months

LEADERSBiolimus

12 months

LEADERSSirolimus

12 months 6 months

PATIENT LEVEL POOLED ANALYSIS4

IDE STUDY Provisional9 months1

Tryton9 months112 months

13.1%

10.9% 9.6%

12.6% 12.8%

16.3%

6.5% 8.5%

15.6%

11.3%

Tryton Studies TVF Rates*Provisional Arm TVF Rates*

TRYTON CLINICAL RESULTS CHALLENGE THE PARADIGM OF PROVISIONAL STRATEGY WITH LOW TLR AND LOW THROMBOSIS RATES

0

2

4

6

8

10

12

14

%

NORDIC I 207 pts 14m FU

CACTUS 173 pts 6m FU

BBC ONE 249 pts 9m FU2

BBK101 pts12m FU

DKCRUSH-II 185 pts 12m FU

LEADERS BES258 pts 12m FU3

LEADERS SES239 pts 12m FU3 707 pts

6m FU

PATIENT LEVEL POOLED ANALYSIS4

IDE STUDY Provisional

143 pts1Tryton

146 pts1261 pts12m FU

6.5%

5.8%5.6%

10.9%

13%

4.7%

12.1%

2.9%

4%4.3%

3.5%

2%

1.1%

0%

3%

1.1%

4.9%

3.6%

0.5% 0.5%0.3%

0.6%

9 m

Tryton Studies Outcomes

Provisional Arm Outcomes

Provisional Thrombosis

Tryton Thrombosis

Provisional TLR

Tryton TLR

1. Side Branch RVD ≥2.25mm 2. TVF rate indicated. 3. Combined 1 and 2 stent strategy. 4. European experience from 8 registries and studies *Data on File at Tryton Medical.

www.trytonmedical.com

@trytonmedical1

trytonmedical

Corporate Headquarters1000 Park Forty Plaza, Suite 325Durham, NC 27713 USA

Tryton Medical B.V.De Tweeling 20-225215 MC‘s HertogenboschThe Netherlands

D21

23G

_V01

Rev

. 1

Device Not Approved for Sale in the US and Japan.

Tryton

Provisional