sustained release. sustained results. - boston scientific · 2019-06-24 · sustained release....

2
Stent diameter (mm) 6 7 Delivery system working length (cm) 75 130 75 130 Minimum sheath size Stent Length (mm) 40 H74939295600470 H74939295600410 H74939295700470 H74939295700410 6F (1,67mm) 60 H74939295600670 H74939295600610 H74939295700670 H74939295700610 6F (1,67mm) 80 H74939295600870 H74939295600810 H74939295700870 H74939295700810 6F (1,67mm) 100 H74939295601070 H74939295601010 H74939295701070 H74939295701010 6F (1,67mm) 120 H74939295601270 H74939295601210 H74939295701270 H74939295701210 6F (1,67mm) 150 H74939295601570 H74939295601510 H74939295701570 H74939295701510 6F (1,67mm) Outer blue stabilizing shaft Pull grip Safety lock Thumbwheel Ergonomic handle Radiopaque stent markers Middle shaft radiopaque marker band Flushing luer Middle shaft Radiopaque tip Inner shaft Triaxial delivery system for more precise and predictable stent placement Highest reported Freedom from TLR rate at 2 years Results from different trials are not directly comparable. Information provided for educational purposes. 1. Rocha-Singh KJ, et al. Catheterization and Cardiovascular Interventions. 2015; 86:164–170. n=287 2. Laird J, et al. J Endovasc Ther. 2012;19:1–9. n=134 3. Data obtained from product SSED found on www.fda.com on 6Sep2016. n=213 4. Dake M, et al. JACC. 2013; 61: 2417-27. n=236 5. Müller-Hülsbeck S. Presented at CIRSE 2016. n=57; represents actual freedom from TLR rate; Kaplan-Meier estimate is 91.3% www.bostonscientific.eu © 2016 Boston Scientific Corporation or its affiliates. All rights reserved. DINPER4672EA CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Information for the use only in countries with applicable health authority product registrations. This material is not for use or distribution in France. Eluvia is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. All other trademarks are property of their respective owners. PI-349603-AA JAN2016 Printed in Germany by medicalvision SUSTAINED RELEASE. SUSTAINED RESULTS. 2-YEAR FREEDOM FROM TLR RATES RUTHERFORD CATEGORY (MAJESTIC TRIAL) 91% OF PATIENTS HAD NO OR MINIMAL CLAUDICATION AT 2 YEARS 100 % 80 % 60 % 40 % 20 % 0 % 75% 78% 84% 87% 92.5% ELUVIA TM Drug-Eluting Vascular Stent System ELUVIA TM Drug-Eluting Vascular Stent System DURABILITY II (EverFlex ) 1 RESILIENT (LifeStent ) 2 SUPERB (Supera ) 3 Zilver PTX Randomized Trial 4 MAJESTIC (Eluvia ) 5 Avg. Lesion Length (cm) 8.9 7.1 7.8 5.4 7.1 Severely calcified 43 % 25 % 45 % 37 % 65 % Total occulusions 48% 17% 25% 38% 46% 4 5 3 2 1 0 100 % 80 % 60 % 40 % 20 % 0 % BASELINE (n=57) 1 MONTH (n=56) 12 MONTHS (n=53) 24 MONTHS (n=53)

Upload: others

Post on 18-Jul-2020

9 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: SuStained ReleaSe. SuSTained ReSuLTS. - Boston Scientific · 2019-06-24 · SuStained ReleaSe. SuSTained ReSuLTS. 2-Year FreeDoM FroM TLr raTeS ruTherForD CaTegorY (MaJeSTIC TrIaL)

Stent diameter (mm)

6 7

Delivery system working length (cm)

75 130 75 130 Minimum sheath size

Sten

t Len

gth

(mm

)

40 H74939295600470 H74939295600410 H74939295700470 H74939295700410 6F (1,67mm)

60 H74939295600670 H74939295600610 H74939295700670 H74939295700610 6F (1,67mm)

80 H74939295600870 H74939295600810 H74939295700870 H74939295700810 6F (1,67mm)

100 H74939295601070 H74939295601010 H74939295701070 H74939295701010 6F (1,67mm)

120 H74939295601270 H74939295601210 H74939295701270 H74939295701210 6F (1,67mm)

150 H74939295601570 H74939295601510 H74939295701570 H74939295701510 6F (1,67mm)

Outer blue stabilizing shaftPull grip

Safety lock

Thumbwheel

Ergonomic handle

Radiopaque stent markers

Middle shaft radiopaque marker band

Flushing luer

Middle shaft

Radiopaque tip Inner shaft

Triaxial delivery system for more precise and predictable stent placementHighest reported Freedom from TLR rate at 2 years

Results from different trials are not directly comparable. Information provided for educational purposes. 1. Rocha-Singh KJ, et al. Catheterization and Cardiovascular Interventions. 2015; 86:164–170. n=287 2. Laird J, et al. J Endovasc Ther. 2012;19:1–9. n=134 3. Data obtained from product SSED found on www.fda.com on 6Sep2016. n=2134. Dake M, et al. JACC. 2013; 61: 2417-27. n=2365. Müller-Hülsbeck S. Presented at CIRSE 2016. n=57; represents actual freedom from TLR rate; Kaplan-Meier estimate is 91.3%

www.bostonscientific.eu

© 2016 Boston Scientific Corporation or its affiliates. All rights reserved.DINPER4672EA

CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Information for the use only in countries with applicable health authority product registrations.

This material is not for use or distribution in France. Eluvia is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. All other trademarks are property of their respective owners. PI-349603-AA JAN2016 Printed in Germany by medicalvision

SuStained ReleaSe.SuSTained ReSuLTS.

2-Year FreeDoM FroM TLr raTeS

ruTherForD CaTegorY (MaJeSTIC TrIaL)

91% oF paTIenTS haD no or MInIMaL CLauDICaTIon aT 2 YearS

100 %

80 %

60 %

40 %

20 %

0 %

75% 78% 84% 87%

92.5%

eLuviaTM drug-eluting vascular Stent System

eLuviaTM drug-eluting vascular Stent System

DurabILITY II(everFlex™)1

reSILIenT(LifeStent™)2

Superb (Supera™)3

Zilver™ pTX™ randomized Trial4

MaJeSTIC (eluvia™)5

Avg. Lesion Length (cm) 8.9 7.1 7.8 5.4 7.1

Severely calcified 43 % 25 % 45 % 37 % 65 %

Total occulusions 48% 17% 25% 38% 46%

4

5

32

1

0

100 %

80 %

60 %

40 %

20 %

0 %

baSeLIne(n=57)

1 MonTh (n=56)

12 MonThS (n=53)

24 MonThS (n=53)

Page 2: SuStained ReleaSe. SuSTained ReSuLTS. - Boston Scientific · 2019-06-24 · SuStained ReleaSe. SuSTained ReSuLTS. 2-Year FreeDoM FroM TLr raTeS ruTherForD CaTegorY (MaJeSTIC TrIaL)

Significant mechanical forces in the SFA prolong the response to injury and make the SFA susceptible to restenosis.

The Eluvia™ Stent, with Sustend™ drug-delivery technology, is designed to deliver paclitaxel when restenosis is most likely to occur.

Polymer-based technology with proven biocompatibility1

Implanted in more than 10 million vessels since 2007

More than 20,000 patients studied in clinical trials

Restenosis following nitinol stenting peaks at about 12 months in the SFA

Time (months) Post-Procedure

% P

RO

BA

BIL

ITY

DE

NS

ITY

OF

RE

ST

EN

OS

IS

CLINICAL HISTORY OF RESTENOSIS

2.5

2.0

1.5

1.0

0.5

0

0 12 24 36 48 60

Iida, O. et al. Catheterization and Cardiovascular Interventions. 2011; 78:611–617. Müller-Hulsbeck S. Presented at CIRSE 2016. Represents actual freedom from TLR rate. Kaplan-Meier estimated freedom from TLR is 91.3%. Data on file at Boston Scientific.

MaJeSTiC CLiniCaL TRiaL

TRIAL OVERVIEW

Core lab adjudicated single-arm, multicenter trial (n=57)

65% of lesions severely calcified

46% total occlusions

71 mm average lesion length

2-yEAR RESuLTS

0 STenT FRaCTuReS

92.5% Freedom from tlR

patients with minimal or no claudication

91 %

Built on the Innova™ Stent platform, designed to optimize:

Flexibility

Radial strength

Fracture resistance

While providing uniform

scaffolding for drug delivery.

* Based on pre-clinical PK analysis. Data on file at Boston Scientific. Dake MD, et al. J Vasc Interv Radiol. 2011;22(5):603-610.

1. Data on file at Boston Scientific.

the Challenge: a Harsh SFa environment

the Solution: Sustained drug Release

the Outcome: unPReCedenTed Results in the SFa

DRUG RELEASE OVER TIME

PA

CLI

TA

XE

L T

ISS

UE

CO

NC

EN

TR

AT

ION

(n

g/m

g)

8

6

4

2

0

0 60 120 180 240 360300Time (days) Post-Procedure

ZILVER™ PTX™

ELUVIA

DRUG RELEASE OVER TIME

PA

CLI

TA

XE

L T

ISS

UE

CO

NC

EN

TR

AT

ION

(n

g/m

g)

8

6

4

2

0

0 60 120 180 240 360300Time (days) Post-Procedure

ZILVER™ PTX™ *

Eluvia

More than 12 months of sustained drug release

Drug TISSue ConCenTraTIonS over TIMe