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Why INTEREST in BTK Lesions“Real-World” lesions in SEA “Real-World” impact for SEA patients THE 15 1 H NATION AL... Stents address a structural issueRole of BMS in BTK post CTO Angiopla

NOTHING MUCH CHANGED

2012

SINCE

THE

15 1 H NATIONAL CONG RESS

OF C ARDIOLO GY

2016

Why INTEREST in BTK Lesions

“Real-World” lesions in SEA

“Real-World” impact for SEA patients

THE

15 1 H NATION AL

60-70% of PVD work is BTK

20-30% at At Ankle

1 st Presentation is Tissue Loss

Long healing time is required

THE

15 1 H NATIONAL CONG RESS

OF C ARDIOLO GY

2016

A Schmidt et al Catheter Cardiovas

2010

Intervent

58 CLI patients 62 limbs

Mean lesion length 183mm

Re-stenosis > 50% after 3 months 68.8%

THE

15 1 H NATIONAL CONG RESS

OF C ARDIOLO GY

2016

Fernandez et al J Vas Surg 2010:52 834-42

Longevity is the main Issue

Stents answer a structural problem

OF C ARDIOLO GY

2016

Stents address a structural issue

Role of BMS in BTK post CTO Angioplasty Salvage

situation

Xu G, Tang ZH, Cheng SC ASVS Kyoto 2010

1 year period 12 Limbs (10 patients) out of 130

Restenosis >50% on duplex/ DSA/CTA

Limbs

Restenosis rate 91.2% by one month follow up

Re-occlusion rate 100% by 4 months

THE

15 1 H NATION AL

YUKON, ACHILLES, DESTINY Trials Short lesions < 3cm

•

• Feasibility across joints/Movement points

• Feasibility of “full metal jacket”

• Stent still remains

Deal with long length lesions

No residual inflammatory reaction inciting stents

No concerns across joints and areas of movement

5-10% may still need stents (?DES) for salvage reasons

THE 15 TH

NATIONAL CONG RESS

201 6

TIMELINE OF EVENTS

2009 0.014 MonoRx Platform

2010 OTW 0.014 Platform Available

2010-2012 DCB Era started withInvatec

2013-Present Lutonix / Ranger

THE

15 1 H NATION AL

• Leipzig BTK Registry Schmidt A et al 2011

• 107 patients treated Amphiron DCB

• 60.5% total occlusion Rutherford class V 63.2%

Medtronic, Inc.

8200 Coral Sea Street NE Mounds View, MN 55112

www.medtronic.com

Urgent Field Safety Notice IN.PACT® Amphirion

Drug-Eluting Balloon (DEB)

November, 2013 Medtronic reference # FA597

Dear Healthcare Professional (Hospital Administrator,

OR Manager, and Risk Manager),

Based on data from the IN.PACT® DEEP clinical study,

Medtronic has decided to voluntarily recall and stop

selling the IN.PACT Amphirion drug-eluting balloon

(DEB) Only the IN.PACT Amphirion DEB is subject to

this recall Other products in the IN.PACT DEB product

family are not subject to this recall

THE

15 1 H NATIONAL CONG RESS

OF C ARDIOLO GY

2016

IN.PACT DEEP Randomized Trial

CD-TLR DEB 9.2% POBA 13.1% p=0.291

LLL DEB 0.61 +/- 0.78mm POBA 0.62 +/- 0.78mm

p=0.950

A safety signal driven by major amputations through

12 months was observed in the IA-DEB

0.080)

arm versus thePTA arm (8.8% vs 3.6%; p =

15 1 H NATIONAL CONG RESS

OF

C ARDIOLO GY

2016

TH E

MEANWHILE IN SINGAPORE

2010-2012

THE

15 1 H NATIONAL CONG RESS

OF C ARDIOLO GY

2016

Tan Tock Seng Hospital Registry 2010 Loong TH etal

24 patients agreed to the use of DEB

DEB use after predilatation with uncoated balloon

Patients that need DES or BMS stent salvage not

OF C ARDIOLO GY

2016

Safety– Acute Re-Thrombosis

Limb Salvage

1 Month 3 Month 6 Month Patency by Duplex

THE

15 1 H NATION AL

DEB Use in BTK Lesions

2 patients passed away > 30

days after intervention from

unrelated causes

19 patients 1 BKA- ascending

infection, vessel patent

THE

15 1 H NATION AL

Mean lesion length 140mm

3

0

0

\ '\

DEBATE-BTK Liistro et al Circulation 2013

Single Center DM CLI patient 1:1 Randomisation

DEB:POBA 132 patients

Primary End-point Binary Stenosis on treated

segment 12 months on US or Angiography

Secondary End Points CD TLR, Amputations

Occlusion

and

THE

15 1 H NATIONAL CONG RESS

OF C ARDIOLO GY

2016

Binary restenosis 27% DEB vs 74% POBA p<0.001 TLR 18% DEB vs 43% POBA p=0.002

Occlusion 17% DEB vs 55% POBA p<0.001

OF C ARDIOLO GY

2016

DCB Default

DES/Self Expanding TPT Salvage

REGION SPECIFIC STUDIES

THANK YOU

THE

15 1 H NATION AL