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Length of the lesion cm Lesion/stent Length and Patency Shillinger,M 2009... Length of the lesion cm PTA plus stent ZILVER PTX ZILVER Balloon suboptimal RESILENT PTA ALONE DES Comp

What are the Novel Devices and

Technologies in 2014 to Treat Peripheral

Current limitations Associated with

Length of the lesion (cm)

Lesion/stent Length and Patency

Shillinger,M 2009

Length of the lesion (cm)

PTA plus stent

ZILVER PTX

ZILVER Balloon suboptimal RESILENT

PTA ALONE

DES

Comparison of SFA Trials

Shillinger & Baumgartner 2010

Length of the lesion (cm)

PTA plus stent

ZILVER PTX

ZILVER PTX Balloon suboptimal RESILENT

PTA ALONE

DES

Comparison of SFA Trials

Shillinger & Baumgartner 2010

VIABAHN

FISCHER

KEDORA

25 CM MCQUADE

25 CM

Standard Nitinol Stents Wire Interwoven Covered/Stent

Current limitations Associated with

Currently No DEB are available for

Below Knee Disease!!

Current limitations of DEB

• Acute dissection

• Significant recoil

• Minimal acute luminal gain

• Presence of Ca+

The Chocolate Balloon

How Does Chocolate Balloon Address These Limitations?

Unique nitinol “constraining structure”

• Shields vessel wall from torsional shear stress

caused by balloon “unfolding”

• Uniformly distributes longitudinal & circumferential forces

• Modifies plaque via:

 “Pillows”: Vessel dilatation without cutting or scoring

 “Grooves”: Stress relief, plaque modification

What Does this Mean Clinically?

• Fewer dissections

• More aggressive sizing

• Increased acute luminal gain

• Longer term patency

• Less stent utilization

Schmidt BTK DEB

Bosiers, PTA Arm

Schmidt BTK PTA

Odink, PTA Study

Bail-Out Stenting Rates

72 year old male

• 2 prior kidney transplants

The ENDURE Chocolate DEB Clinical Trial -

Design

• Single or Tandem de novo lesion

• Total lesion length ≤ 150 mm

• RVD 2.0 – 6.0 mm

• Rutherford Grade 3-5

Up to 5 sites in New Zealand and Europe; Up to 80 patients; Single-Arm Trial

• Late Lumen Loss – Angiography (QVA Core Lab)

• Patency Rate – Duplex Ultrasound (dUS Core Lab)

• TLR Rate

• Amputation Free Survival

• Rutherford Grade change

Why CTOs are a Problem?

• Time Commitment & skill set

Lancet 2005 Dec 3;366(9501):1925-34

Over 30% of CTOs Can Not be Crossed

in the Antegrade Approach

Lancet 2005 Dec 3;366(9501):1925-34

J Endovasc Ther 2008;15:594–604

83 year old female

EVENTS

• Seen by vascular surgery 03/2012

• Offered Fem-BK bypass and TMA

• Refused TMA

• Late March Undergo Fem-BK bypass using vein

• Early April with severe rest pain

• Graft occluded –long TPA and Angioplasty

EVENTS

• A few hours later with no pulse in the foot

• Repeat angiogram shows graft is occluded

• Again angioplasty and Lovenox

• Offered BKA but she refused

• Discharged

• Mid April came to see me crying in rest pain

0.18

Post Procedure

Post Procedure

4 Weeks Post-intervention

THANK YOU!!