Just stent it? Biomimetic interwoven stents

Craig M. Walker, MD, FACC, FACP

Clinical Professor of Medicine

Tulane University School of Medicine

New Orleans, LA

Clinical Professor of Medicine

LSU School of Medicine

New Orleans, LA

Founder, President, and Medical Director

Cardiovascular Institute of the South

Houma, LA

Disclosure

Speaker name:

.................................................................................

I have the following potential conflicts of interest to report:

Consulting

Employment in industry

Stockholder of a healthcare company

Owner of a healthcare company

Other(s)

I do not have any potential conflict of interest

X

Dense arterial calcification is a problem

• Most calcium is located in the media not the intima

• Calcium is associated with less optimal outcomes in most interventional series

• There are many talks but NO RANDOMIZED TRIALS to guide us in the interventional therapy of calcific SFA disease.

There are no randomized controlled trials in calcified SFA intervention comparing various

therapies to each other.

The SUPERA Stent

• SUPERA is an interwoven self-expanding nitinol stent

• The design incorporates 6 pairs of super-elastic nitinol wires which are interwoven in a helical pattern with a closed cell geometry

References 1. Flexibility is defined as kink resistance. Supera® implant demonstrated lowest kink resistance for 5 and 6 x 100 mm implants as compared to 6 x 100 mm standard nitinol implants in a tube. Data on file at Abbott Vascular. 2. 20 lbf compression resistance for 5 x 100 mm Supera® implant to achieve 53% compression. Four times the compression resistance of all other competitors. All other products compressed 53% with less than 5 lbf applied. Data on file at Abbott Vascular. 3. 10 million cycles (equivalent of 10 years of human activity) of independent lab bending, extension, torsion and compression testing.

0.00

0.05

0.10

0.15

0.20

0.25

0.00 0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00

Forc

e (

lbs/

mm

)

Deflection (mm)

Greater than 4x compression resistance2

Supera® 6.5 x 100 mm

Supera® 5.5 x 100 mm

Standard Nitinol Stents 6.0 x 100 mm

Unparalleled Strength The Supera® implant has 20 lb. compression resistance2

Unlike Standard Nitinol Stents (SNS), Supera’s Vascular Mimetic Technology offers

unparalleled strength and flexibility.

Kink Compression

Standard

Nitinol

Stents

Supera®

Fracture

>4x compression resistance vs.

SNS1

Zero fractures at 1 year across

1400+ patients2

Greatest kink resistance

of any SFA stent1

1. Flexibility is defined as kink resistance. Supera® implant demonstrated lowest kink resistance for 5.5 and 6.5 x 100 mm implants as compared to 6 x 100 mm standard nitinol stents in a tube. Data on file at Abbott Vascular.

2. 1,152 patients analyzed retrospectively, see Scheinert, et al., Real world perspectives of treating complex SFA-Pop lesions, Results from the SUPERA-500 (including Leipzig SFA,

Leipzig Popliteal and S500 LL) Registry, LINC 2013, 495 patients; Goverde, et al., AURORRAregistry: Experience with high radial force interwoven nitinol stents in femoropopliteal arteries, LINC 2013, 117 patients; Molenaar,

et al., Interwoven self-expanding nitinol stents for long complex SFA and popliteal lesions CWZ, LINC 2012, 178 patients; Goltz, et al., Endovascular Treatment of Popliteal Artery Segments P1 and P2 in Patients with Critical

Limb Ischemia, J Endovasc Ther 2012;19:450-456, 40 patients; Chan, et al., HK Single-centre Results of Femoro-popliteal Revascularization using Helical Interwoven Nitinol Stents, LINC 2013, 75 patients; Pacanowski, et al.,

RESTORE: Interwoven Stents in the Real World, The Initial United States Experience with the Use of the Supera Stent in the SFA and Popliteal Artery, LINC 2013, 147 patients; Kovach, R., SAKE, Supera Interwoven Nitinol

Stent Outcomes in Above-Knee Interventions: A Single Center Experience, LINC 2013, 100 patients.

Angio photos courtesy of Dr. Dierk Schienert (top row) and SUPERB study (bottom row). IVUS images courtesy of Dr. Dierk Scheinert and Dr. Frank Arena. Kink photos on file at Abbott Vascular.

Supera® is a New Class of SFA Technology

6 MFU – X-ray 6MFU Cine

Correction of Ca++ Induced Stent Deformation

Courtesy of D. Cohen

Baseline Post BMS Supera restores max stent lumen CSA

Data on file at Abbott Vascular.

Supera® Has Strong Clinical Outcomes in Calcification

SUPERB Data - Severe Calcification

Patency (VIVA 12 months) 89%

Freedom from TLR at 1 year

(K-M) 95%

Freedom from TLR at 2 years

(K-M) 92%

% of Lesions with Severe

Calcification (SUPERB Trial) 45% (n=118)

87.7% 84.6% 87.7%

0%

50%

100%

Shortest Lesions(35.4±12.3cm)

Middle Lesions(73.5±10.8cm)

Longest Lesions(126.1±33.4cm)

Percent of Lesions without Restenosis by Lesion Length

(12 months SUPERB IDE Trial)

Shortest Lesions (35.4 ±12.3 mm)

n=87

Source: Supera® Peripheral Stent System Instructions for Use. Image from SUPERB trial. Data on file at Abbott Vascular.

Middle Lesions (73.5 ±10.8 mm)

n=88

Longest Lesions (126.1 ±33.4 mm)

n=87

Patency Rates are Consistent Across Lesion Lengths

Low Re-intervention Rate Out to 2 Years

Optimal deployment leads to durable freedom from Target Lesion

Revascularization, maintained out to 2 years.

Clinical data on file at Abbott Vascular.

Fre

ed

om

fro

m T

LR (

K-M

)

by

Pe

rce

nt

Co

mp

ress

ion

/

Elo

ng

atio

n a

t 1 a

nd

2 y

rs

Freedom from TLR at 1 year and 2 years

97%

90% 91%

84% 87%

77%

96% 90%

87%

78% 82%

62%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Nominal (±10%) Moderate Compression

(21-40%)

Minimal Compression

(11-20%)

Minimal Elongation

(11-20%)

Moderate Elongation

(21-40%)

Severe Elongation

(>40%)

Freedom from TLR at 1 year (K-M) Free from TLR at 2 years (K-M)

n=6 n=38 n=39 n=26 n=74 n=22

High patency rates are demonstrated in cases where appropriate implant selection, vessel preparation, and deployment technique are used.

Proper Sizing, Preparation, Deployment Technique

Result in Excellent Patency Rates

90,5%

83,3% 81,8%

73,7% 74,4%

57,7%

0%

20%

40%

60%

80%

100%

Nominaln=74

ModerateCompression

n=6

MinimalCompression n=22

MinimalElongation

n=38

ModerateElongation

n=39

SevereElongation

n=26

p=0.480 p=0.268

p=0.026 p=0.029

p=<.001

21-40% 11-20% 11-20% 21-40% >41% ±10%

Prim

ary

Pa

ten

cy (

K-M

)

by P

erc

en

t C

om

pre

ssio

n/E

lon

ga

tio

n

at

12

mo

nth

s

Source: Supera® Peripheral Stent System Summary of Safety and Effectiveness Data (SSED).

Pre-dilate; Size 1:1; Deploy Slowly:

The 3 Keys for Optimal Supera Deployments

“The most important keys for a Supera® case

are a good balloon and careful vessel

preparation.” - Dr. Peter Goverde, Vascular Surgeon, Belgium (has performed over 200 Supera cases)

1. Pre-dilate

Pre-dilate the lesion to ≥ the outer diameter

of the implant.

Longer inflation times recommended.

2. Size 1:1

Match implant size 1:1 to vessel diameter.

Do not oversize the implant.

3. Deploy Slowly

Magnify imaging to observe cell geometry.

Use short, even throws of the thumb slide.

Open the deployment lock and fully

advance thumb slide to completely release

the implant.

Visually confirm implant detachment.

Retract the tip and lock the thumb slide

before withdrawal.

Post-dilate as needed.

Before Lesion Dilatation Post Implant

Supera Limitations

• Difficult to land precisely at the SFA

ostium

• Does not conform well in areas of size

mismatch

• Must utilize an .018 or .014 wire

• Present maximal available length is

12cm

Just stent it? Biomimetic interwoven stents

Craig M. Walker, MD, FACC, FACP

Clinical Professor of Medicine

Tulane University School of Medicine

New Orleans, LA

Clinical Professor of Medicine

LSU School of Medicine

New Orleans, LA

Founder, President, and Medical Director

Cardiovascular Institute of the South

Houma, LA