LINC 2015 – Global Expert Exchange Forum – January 28, 2015

Intravascular Imaging Insights into the Mechanism

of Action of Focal Force Balloon Angioplasty

Sahil A. Parikh, M.D.

Assistant Professor of Medicine

Director, Research and Innovation Center

Director, Experimental Interventional Cardiology Laboratory

Director, Interventional Cardiology Fellowship Program

Harrington Heart & Vascular Institute

University Hospitals Case Medical Center

Case Western Reserve University School of Medicine

Disclosure

Speaker name:

Sahil A. Parikh, MD

I have the following potential conflicts of interest to report:

Consulting: Angioscore/Spectranetics, TriReme, Cordis, St. Jude

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

Short Segment Occlusion PTA: Satisfactory Angiographic Result?

Sahil A. Parikh, MD

OCT of TP Trunk Post PTA

POBA Mechanism of Action

MoA 1: Unfolding expansion results in: • Shear stress

MoA 2: Uncontrolled expansion results in:

• Dilatation in “path of least resistance”

MoA 1 + 2 = Vessel Trauma (torsional, radial, longitudinal)

Vessel trauma manifests as:

• Severe dissections

• Elastic recoil

• Abrupt closure

Today’s solution: STENTS

Pre-Inflation During Inflation End of Inflation

Inflated

Balloon

Plaque Plaque

Plaque

Sheer Stress

Formation

Dissection

Half-way

Inflated

Balloon

Folded

Balloon

Goal: Provide “stent-like” results without permanent implant

Design by TriReme Medical: Unique nitinol “constraining structure”

• Shields vessel wall from torsional shear stress caused by balloon

“unfolding”

• Uniformly distributes longitudinal & circumferential forces

• Modifies plaque via:

“Modules”: Vessel dilatation without cutting or scoring

“Grooves”: Stress relief, plaque modification

• Reduces dissections

• Fast deflation, concentric secondary profile

Chocolate® Design and MoA

“Grooves“

[Modules project beyond constraining structure]

MRK394 rev A

Balloon Effect on Simulated Artery Finite Element Analysis Computer Images

FEA simulation shows significantly less vessel trauma vs. alternatives

PTA Balloon Chocolate Balloon Scoring Balloon

Plaque

High Stress

Low Stress

Plaque

High Stress

Low Stress

Plaque

High Stress

Low Stress

Courtesy: TriReme Medical

BTK Procedural Success N=174

No Flow Limiting Dissection 99%

(173/174)

Achieved <30% Diameter Stenosis

physician visual estimate

94%

(163/174)

Freedom from Bail-Out Stenting 97%

(168/174)

Dissection Rates

1%

8%

12%

Chocolate BAR Odink, PTA

Study

Bosiers, PTA

Arm

Bail-Out Stenting Rates

3% 5%

12% 14%

20%

Chocolate

BAR

Schmidt

BTK DEB

Bosiers,

PTA Arm

Schmidt

BTK PTA

Odink,

PTA Study

How does

this

compare?

Odink H, van den Berg A, Winkens B. Technical and clinical long-term results of infrapopliteal percutaneous transluminal angioplasty for critical limb ischemia. J Vasc Inter radio. Apr 2012: 23(4):461-467

Boisers M, Scheinert D, Peetrs P, Torsello G, Zeller T, Delosse K, Schmidt A, Tosserek J, Vinck E, Schwartz L. Randomized comparison of everolimus-eluting versus bare-metal stents in patients with critical limb ischemia and infrapopliteal arterial occlusive

disease. J Vasc Surg Feb 201255(2):390-398

Schmidt A, Piorkowski M, Werner M, Ulrich M, Bausback Y, Braunlich S, Ick H, Schuster J, Botsios S, Kruse H, Varcoe R, Scheinert D. First Experience with Drug-Eluting Balloons in Infrapopliteal Arteries. JACC Sep 2011 58(11): 1105-1109

Schmidt A, Ulrich M, Winkler B, Klaeffling C, Bausback Y, Braunlich S, Botsios S, Kruse H, Varcoe R, Scheinert D. Angiographic Patency and Clinical Outcome After Balloon-Angioplasty for Extensive Infrapopliteal Arterial Disease.

Courtesy: Tony Das and Jihad Mustapha, LINC 2014

Plaque Composition

Courtesy: Hiram Bezerra, MD and Marco Costa, MD, PhD

Angioplasty of Calcified Lesions: Fracture

Courtesy: Hiram Bezerra, MD and Marco Costa, MD, PhD

Partial Calcium Fracture Complete Calcium Fracture

No Fracture: Dissection

Case Example: Lipid Rich Plaque with Medial Calcification

Treatment with Chocolate 4.0x40mm

Localized Dissection without Extension

Case Example: Calcified Lesion

Case Example: Fibrotic LesionAnastomosis

Numerous Examples

CONCLUSIONS • Focal Force Balloons have a unique mechanism of

action compared to conventional PTA balloons

• These devices demonstrate good acute performance in ATK and BTK lesions when looking at registry data in a representative group of patients

• Heterogenous lesion composition confounds our ability to identify specific lesion types which may be particularly well-suited to treatment with these devices

• Imaging analysis suggests less intimal disruption

Chocolate OCT: ClinicalTrials.Gov: NCT02237066

LINC 2015 – Global Expert Exchange Forum – January 28, 2015

Intravascular Imaging Insights into the Mechanism

of Action of Focal Force Balloon Angioplasty

Sahil A. Parikh, M.D.

Assistant Professor of Medicine

Director, Research and Innovation Center

Director, Experimental Interventional Cardiology Laboratory

Director, Interventional Cardiology Fellowship Program

Harrington Heart & Vascular Institute

University Hospitals Case Medical Center

Case Western Reserve University School of Medicine