PiCSO®

Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO).
A novel first-line therapy used during PCI to positively change the course for Acute MI patients.

PiCSO®

Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO).
A novel first-line therapy used during PCI to positively change the course for Acute MI patients.

PiCSO®

Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO). A novel first-line therapy used during PCI to positively change the course for Acute MI patients.

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.

  • 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

References

  1. SWEDEHEART, ESC 2018
  2. Cahill TJ, Kharbanda RK. Heart failure after myocardial infarction in the era of primary percutaneous coronary intervention: Mechanisms, incidence and identification of patients at risk. World J Cardiol. 2017;9(5):407-415
  3. Mean of 22 PiCSO patients vs. 58 propensity score matched controls. Egred, M., et al., Effect of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) on infarct size in anterior STEMI: PiCSO in ACS study. Int J Cardiol Heart Vasc, 2020. 28: p. 100526
  4. Median of 14 PiCSO patients with pre-stenting IMR>40 vs. 24 parallel controls with pre-stenting IMR>40. De Maria, G.L., et al., Index of microcirculatory resistance-guided therapy with pressure-controlled intermittent coronary sinus occlusion improves coronary microvascular function and reduces infarct size in patients with ST-elevation myocardial infarction: the Oxford Acute Myocardial Infarction – Pressure-controlled Intermittent Coronary Sinus Occlusion study (OxAMI-PICSO study). EuroIntervention, 2018. 14(3): p. e352-e359
  5. Polynomial regression analysis using “PiCSO in ACS” study results based on Stone, G.W., et al., Relationship Between Infarct Size and Outcomes Following Primary PCI: Patient-Level Analysis From 10 Randomized Trials. J Am Coll Cardiol, 2016. 67(14): p. 1674-83
  6. Subgroup analysis of TIMI 0-1 PiCSO treated patients in “PiCSO in ACS” study compared to matched data from 10 RCT control patient data set from on Stone, G.W., et al., Relationship Between Infarct Size and Outcomes Following Primary PCI: Patient-Level Analysis From 10 Randomized Trials. J Am Coll Cardiol, 2016. 67(14): p. 1674-83

PiCSO therapy

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 therapy workflow

No delay in door-to-balloon time

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

Unique mode of action

addresses both ischemic and reperfusion injury