Heart Failure is a progressive disorder

1
Heart Failure

• Heart Failure is a progressive disorder
• Characterized by an enlarged heart with a
  decreased ability to pump blood.
• Enlargement leads to progressive structural and
  functional changes (ventricular remodeling)
• Heart size predicts mortality in heart failure
  patients

Affects 5 million people in the US and 25 million
people worldwide. 550,000 new cases diagnosed
each year in US
2
Heart Failure Treatment Options
NYHA II 1.7 Million Patients
NYHA III 1.4 Million Patients
NYHA IV 367,000 Patients
DRUG THERAPY
INTERVENTIONS
END STAGE

• Transplant
• LVAD
• TAH

Patient Has Consider QRS gt 135
CRT 3 / 4 MR MV Repair
Advanced CAD CABG Progressive
Enlargement (Wall stress)
LVEDDgt60 LVEFlt35

• Relieves HF Symptoms
• Diuretics
• Inotropes
• Slow HF Progression
• ACE Inhibitors
• Beta Blockers

• ?????

Source NYHA Class Populations Health Research
International 2004
3
CorCap Cardiac Support Device

• The CorCap is designed to
• Provide end-diastolic ventricular support to
  reduce wall stress and myocardial stretch
• Negate the stimuli for ventricular remodeling and
  promote myocardial reverse remodeling
• Reverse progressive dilation and improve cardiac
  function and patient functional status

4
CorCap Cardiac Support Device

• Multi-Filament Yarn / Knit Fabric
• 4 Key Design Features
• Optimal compliance - stretchiness
• Bi-directional Properties
• Reshapes the heart to ellipsoid
• 31 micro fiber construction
• Smooth fit on surface of heart
• Long term biocompatibility
• Materials used in other implantable devices

5
How does the CorCap CSD work?
Injury
Decreased Cardiac Function
CorCap CSD
Increased Myocyte Stretch
Increase Wall Stress
Heart Failure Symptoms
(NYHA Class, Hospitalizations)
Diastolic Wall Stress Radius x Transmural
Pressure (Myocyte Stretch)
Wall Thickness Transmural Pressure LVEDP
CorCap Counter Pressure
6
CorCap Cardiac Support Device

• Proof-of-concept studies completed in 3 different
  animal models of heart failure
• Human safety experience demonstrates structural
  clinical benefit out to 4 years

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Current Implant Procedure
30 Minute Procedure
Position CorCap
Longitudinal Seam
Adjust Fit
1.
2.
3.
Implantation Complete
Final Seam Secured
Trim Excess Fabric
4.
5.
6.

• Compliments Other HF Therapies
• Beating Heart Procedure

• Potential for Minimally Invasive Procedure

8
Acorn Clinical Trial Design
300 Patients
Mitral Surgery Stratum 193 Patients
No Mitral Surgery Stratum 107 Patients
(Randomized)
(Randomized)
Control MVR Alone 102 Patients
Treatment MVR plus CSD 91 Patients
Control Med Rx Alone 50 Patients
Treatment Med Rx plus CSD 57 Patients
Median follow-up of 23 Months 504 patient years
of follow-up