NOTHING MUCH CHANGED

SINCE

2012

THE 151HNATIONAL CONGRESS

OF CARDIOLOGY

2016


Why INTEREST in BTK Lesions
“Real-World”

lesions in SEA

“Real-World”

impact for SEA patients

THE 151HNATIONAL CONGRESS

OF CARDIOLOGY

2016


60-70% of PVD work is BTK
20-30% at At Ankle


111 CLI patients
1 year follow up
Duplex patency 33%
Re-intervention rate



Feasibility across joints/Movement

•

Feasibility of “full metal jacket”

•

Stent still remains

points


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 CONGRESS

OF CARDIOLOGY

2016


TIMELINE OF EVENTS
2009

0.014 MonoRx Platform

Angiographic evidence of >50%
stenosis at 3 months

BTK POBA

BTK DEB

69%

27%


Medtronic, Inc.
8200 Coral Sea Street NE Mounds View, MN 55112
www.medtronic.com
Urgent Field Safety Notice IN.PACT® Amphirion DrugEluting 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
THE 151HNATIONAL CONGRESS

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

OF CARDIOLOGY

2016



0.62 +/- 0.78mm

A safety signal driven by major amputations through
the IA-DEB arm versus the
12 months was observed in
PTA arm (8.8% vs. 3.6%; p =
0.080).

THE 151HNATIONAL CONGRESS

OF CARDIOLOGY

2016


MEANWHILE IN SINGAPORE
2010-2012

THE 151HNATIONAL CONGRESS

OF CARDIOLOGY

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


Males

12 ( 57%)

Females

9 (43%)

DM

19 (90%)

HPT

16 (76%)

Hyperlipidaemia

13 (62%)

IHD

8 (38%)

Smoking

2 (10%)