MiStent SES ® Program Technology and Clinical Data Update PowerPoint Presentation, PPT - DocSlides

MiStent SES ®  Program Technology and Clinical Data Update PowerPoint Presentation, PPT - DocSlides

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David . Kandzari. , MD. Monday, February 22. 11:41-11:48 pm. Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the . organization(s. ) listed below. ID: 636397

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Presentations text content in MiStent SES ® Program Technology and Clinical Data Update

Slide1

MiStent SES® Program Technology and Clinical Data Update

David

Kandzari

, MD

Monday, February 22

11:41-11:48 pm

Slide2

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 Company

Grant/Research Support

Abbott

Vascular, Boston Scientific,

Medtronic

CardioVascular

,

Biotronik

,

Thoratec

Consulting Fees/Honoraria

Boston

Scientific Corporation,

Medtronic

CardioVascular

,

Micell

Major Stock Shareholder/Equity None

Royalty Income

None

Ownership/Founder

None

Intellectual Property Rights

None

Other Financial Benefit

None

Slide3

MiStent Crystalline SirolimusUnique to MiStent SES, the

sirolimus

is maintained in a

micro-crystalline morphology for controlled and prolonged elution, as opposed to use of an amorphous, rapid-release form of the drug.

REDEFINING DES – CRYSTALLINE SIROLIMUS WITH A RAPIDLY ABSORBED POLYMER COATING

MiStent

Thin-Strut Stent

Cobalt-chromium

Highly

deliverable (64 microns)

Reference: Carlyle et al, JCR 162 (2012) 561–567.

Slide4

MISTENT SES: COMPARATIVE STRUT THICKNESS

Strut Thickness (µm)

BVS

150µm

BioMatrix

Flex

120µm

Resolute

Integrity

89µm PROMUSElement 81µm

XIENCE V

81µm

MiStent 64µm

Thinner struts are associated with more rapid healing and lower risk of acute

thrombogenicity

Kolandaivelu

, K., et al.

Circulation

2011,

123(13), 1

400-1409.

Adapted from K. Dawkins, CRT 2013.

SYNERGY 74µm

Slide5

DRUG DELIVERY VS POLYMER DISSOLUTION

References: Carlyle et al, JCR 162 (2012) 561–567.

Adapted from Dawkins TCT2014 & product websites

MiStent SES – Crystalline drug presence in the tissue after elimination of polymer

Minimizes duration of inflammatory effect of

polymerRetains anti-restenotic drug for 3X longer than polymer is present

Slide6

UNIQUE MECHANISM OF DRUG DELIVERY

Crystalline

s

irolimus

provides sustained elution to limit disease progression

Controlled drug release from moment of deployment

MiStent SES

An initial uncontrolled burst of drug may delay re-endothelialisation

and coverage of the stent struts11 Deconinck E, et al. Pharmaceutical Aspects of Drug Eluting Stents. Journal of Pharmaceutical Sciences, 97(12), 5047-5060 (2008).

Slide7

DESSOLVE I: STUDY DESIGN

First-in-Human, 30 patients, 5 sites

Mechanistic design to investigate quality of vessel healing

4, 6, 8-month data - angiography, IVUS, OCT

18-month data - angiography, IVUS,

OCT

PROCEDURE

30D

4M

6M

8M

12M

18M

2Y

3Y

4Y

5Y

4M

(n=10)

Angio, IVUS

, OCT

6M

(n=10)

Angio, IVUS, OCT

8M

(n=10)

Angio, IVUS,

OCT

8M

(

n=30

)

Clinical

12M

(n=30)

Clinical

Follow-Up

(n=27)

Angio,

IVUS, OCT

18M

(n=30)

Clinical

Enrolled

(n=30)

5 sites

Ormiston

, J.,

et al

. (2013).

JACC Cl

6

(10),

1026-1033.

2

, 3, 4, 5Y

Long-term

Clinical

Follow-up

4-Year Completed

Slide8

DESSOLVE I: SAFETY AT 4 YEARS

No Target Lesion Failure

No

Target Lesion Related MACE 1 MI – Non-Target Vessel NQW-MI at 44 days 1 MI – Non-Target Vessel NQW-MI at 732 days 1 TVR at 1280 days No Stent Thrombosis

MACETLF1 year3.3% (1/30) 0% (0/30)2 years3.4% (1/29) 0% (0/29)3 years6.9% (2/29)0% (0/29)4 years

10.3% (3/29)

0% (0/29)

Slide9

DESSOLVE I: IMAGING RESULTS

Healing demonstrated by OCT

through

18

months OCT Results

Imaging with OCT demonstrated thin, homogeneous coverage with high rates of stent strut coverage at 6 - 8 monthsNo evidence of definite neoatherosclerosis at 18 months

Thin homogeneous tissue coverage

Median

4-Month Group

6-Month Group8-Month Group18-Month Group% Strut Coverage93%97%96%100%References: Ormiston J, et al.

JACC CI

2013

Attizzani

G, et al.

Am J Card

2013

Slide10

DESSOLVE II: STUDY DESIGN

2:1 RCT design for superiority of in-stent LLL at 9 months with Endeavor

184 patients at 26 sites

2:1 RCT

26 sites

MiStent SES

n

=123

Endeavor

n=61

PROCEDURE

30D

6M

9M

12M

2Y

3

Y

4Y

5Y

9M

-

MiStent

SES

Angio, OCT

, EFT, Clinical

9M

- Endeavor

Angio, OCT, EFT, Clinical

12M

n=175

Clinical

Follow-Up

2

, 3, 4, 5Y

Long-term

Clinical

Follow-up

4-Year Completed

Wijns

W et al.

EuroInterv

2015;10:1383-1390

MiStent SES

LLL

was significantly lower than Endeavor at 9 months

0.27 ± 0.46

vs

0.58 ±

0.41

P

<0.001

Slide11

P=0.27

P=1.00

P=0.72

P=0.18

P=1.00

P=0.31

P=0.33

DESSOLVE II: 4-Year Clinical Outcomes

Slide12

12

DESSOLVE II: 4-Year Clinical Outcomes

The MiStent

®

Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES) has received the CE Mark but is not approved for sale or use in the United States by the FDA.

Confidential

Slide13

ABSENCE OF LLL CATCH-UP TRANSLATES TO LOW TLR PROGRESSION

No Progression of In-stent Late Lumen Loss From

6/8

to 18 Months Follow Up

Results in low progression of target lesion revascularization (TLR) at 4 YearsAngiography In-Stent Late Lumen Loss

CD-TLR Over TimeOrmiston, J., et al. (2013). JACC Cl 6 (10), 1026-1033

Data on file - Micell

N=152

Slide14

Comparison of Late-Term TLR with EES

Lansky, Byrne, et al.

EuroPCR

2015

Slide15

ONGOING CLINICAL STUDIES

Building

on the success of the DESSOLVE I and II studies,

three

additional studies

initiated in 2015China Approval StudyRCT vs Tivoli DESN = 400 pts9-Month LLL, 12-Month TLFInitiated Q2 2015

DESSOLVE III Study

Post-Marketing RCT vs Xience

N = 1400 pts12-Month TLFEnrollment completed 12/2015

DESSOLVE III Sub-StudyOCT RCT Sub-StudyN = 60 ptsSuperiority for progression of NIH over timeInitiation Q4 2015

Slide16

SUMMARY OF MISTENT PERFORMANCE

MiStent converts to a BMS in 45 - 60 days and all polymer is absorbed in 90 days

Therapeutic levels of sirolimus in tissue is maintained beyond the polymer absorption due to use of crystalline drug

4-year pooled DESSOLVE I and II CD-TLR rate is 2.7%

No probable or definite ST through 4 yearsMiStent has no late catch-up resulting in a low progression of TLR over long-term follow-up potential for significant health economic benefits based on fewer f/u TLRs

Slide17

MiStent Design Capitalizing on Lessons Learned and Novel Discovery

1. There is an undesirable consequence of both extremes, when the scaffolding is removed or inordinately thick— we have experienced this with both thick struts stents but also

bioresorbable

scaffolding

2. Elution of drug from the polymer is only a limited component of controlled drug delivery—formulation of drug, dispersion throughout tissue, duration of effect and dwell time are all essential and yet underappreciated components 3. MiStent incorporates advantages of stent-based and balloon-based systems, representing delivery of stent coating and drug yet independent of stent scaffolding 4. Crystalline formulation of sirolimus permits more uniform dosing, without focal excess or minimal concentrations, and without initial burst of drug release 5. Both by flow of coating and delivery of crystalline drug, there is a distinct advantage of drug persistence after polymer dissolution

Slide18

Slide19


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