PiCSO - Pressure-controlled intermittent Coronary Sinus Occlusion

• PiCSO demonstrated an infarct size reduction of 33% in STEMI (ST-Elevation Myocardial Infarction) patients which represents a 7% absolute reduction3
• Modeled on this reduction of infarct size, PiCSO may result in5:
• 34% reduction in heart failure hospitalization
• 25% reduction in mortality at 1-year

Superior results in STEMI patients with TIMI 0/16

This subpopulation has shown even stronger results when compared to a reference group:

• 49% relative infarct size reduction, which represents a 15.6% absolute reduction

Intended to reduce infarct size by intermittent coronary sinus occlusion during PCI.

Aims to redistribute blood flow to damaged areas in patients with Acute MI.

• Predictable and smooth delivery with short learning curve
• Employs standard approach via femoral vein
• Fits into existing workflow following flow restoration and stenting
• Streamlined procedure adds only 33 minutes to procedure

Minimize risk in an urgent situation

• Automated and responsive balloon inflation and deflation
• Advanced software adapts to different anatomies

Substantial cost savings

Revolutionizes the current standard of care, leading to improvement in quality of life, and reduction in health care cost at one year.

PiCSO clears the microcirculation to salvage and detoxify myocardium

Intermittent coronary sinus occlusion temporarily increases pressure which may lead to:

• Redistribution of blood flow from normal perfused areas to deprived myocardium
• Clearing of microvascular obstruction
• Enhanced washout of deleterious agents from the microcirculation

THE MORTALITY RATE ASSOCIATED WITH STEMI HAS PLATEAUED OVER THE LAST DECADE1.

UP TO 28% OF PATIENTS DEVELOP HEART FAILURE 90-DAYS POST-ACUTE MI DESPITE BEST PRACTICE PCI2.

Reduction matters. Most.

Infarct size is strongly associated with subsequent mortality, heart failure and hospitalizations following Acute MI.

PiCSO clinical studies have demonstrated significant reduction in infarct size.