New Solutions for Small Vessels

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New Solutions for Small Vessels

• Alexandre Abizaid, MD, PhD
• Chief Coronary Interventions
• Institute Dante Pazzanese of Cardiology
• Sao Paulo, Brazil
• Visiting Professor of Medicine
• Columbia University, New York, USA

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DES Performance in Small Vessels

• Low restenosis rates with DES are leading to
  treatment of more difficult anatomies and smaller
  vessels

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The New Frontiers

• Extended treatment areas
• Small vessels (lt3.0mm)
• Diffuse disease
• Diabetes
• Bifurcation
• Chronic Total Occlusion (CTO)
• Prevention (Vulnerable plaque)

Access and delivery challenges limit optimum
treatment
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Need for Application Specific Designs

• Current balloon expandable stents are difficult
  to deliver to distal or tortuous sites
• Current stents are not designed to address unique
  needs of small vessel anatomy

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CardioMind's .014 Stent Delivery Platform

• A guidewire based platform technology for
  delivery and deployment of stents to small
  vessels and tortuous vascular anatomy

Standard Balloon Catheter
0.014
CardioMind Device
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A New System That Shifts Stent Delivery From
Over-the-Balloon To In-the-Wire
2.5mm BC
.014 CMI System
.014 Guidewire
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The CardioMind System

• CMI Delivery System
• .014 profile along entire length
• Guidewire tip
• PTCA catheter compatible
• Unparalleled deliverability
• Precise stent deployment

Caution Investigational Device Not available
for sale in the United States
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Custom Designed Stent for Small Vessel Disease
Strut Thickness lt.003
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Acute Animal Study Experience

• 10 acute studies in the pig model
• gt 50 deployments of 2.0-3.5 mm stents in coronary
  vessels of pigs
• Full range of stent lengths from 8mm to 28 mm
• Bare wire and through the lumen deliveries

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IVUS Demonstration of Excellent Conformability
IVUS of 3X18 mm stent in porcine RCA Courtesy of
the Y Hongo, Y Honda, P Fitzgerald,
Cardiovascular Core Analysis Laboratory, Stanford
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Chronic Animal Study Results

• CMI stents are well tolerated within the coronary
  vasculature
• Minimal inflammatory response and favorable lumen
  area maintained by favorable remodeling of the
  vascular wall at both 28 and 90 days in porcine
  model

(Animal 9-4
RCA 28 day Courtesy of the C. Rogers, A.
Groothuis, and P. Seifert, ECI Laboratory,
Brigham and Women's Hospital
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CARE I Bare Metal FIM
Single De Novo Native Coronary Artery Lesions
Vessel Diameters 2.0 3.0 m Lesion Length 14
mm Primary Stent Length 18 mm N30 pts
Clinical Follow-Up
30d 6mo 9mo 12 mo 2yr 3yr
Angiographic / IVUS Follow-Up
Primary Endpoint MACE at 30 days (death, MI
and TVR) Key Secondary Endpoints Sub acute
thrombosis (SAT) Device, Lesion and
Procedure Success MACE at hospital discharge,
6, 9 12 mos Clinically driven TLR and TVF
at 6, 9 12 mos ABR, LL and volume
obstruction at 6 12 mos Anti-Platelet Therapy
for 3 months
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Drug Eluting .014 Stent Delivery System Under
Development

• Drug with durable polymer coating
• Good adhesion and flexibility of coating to stent
  seen in preclinical studies
• Animal studies in process

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• BACK-UP SLIDES

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The DES Advantage for Difficult Lesions
Drug Eluting Stent
Bare Metal Stent
Stent
Neointima
Neointima
Stent
Lumen
Lumen
8-month FU
8-month FU