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In the TherOx DownStream Cartridge, pressurized, hospital-supplied oxygen is dissolved into normal saline. The DownStream Cartridge continuously draws blood from the patient using the existing access site from the coronary stenting procedure. Patient blood is mixed with superoxygenated saline created in the cartridge, producing 7 times the normal oxygen concentration (1000 mmHg) in the blood. This superoxygenated blood is then returned directly to the coronary artery via the delivery catheter which is placed at the ostium of the left coronary artery. The procedure requires a 5 - 10 minute setup time and a one-time, 60 minute infusion.

The Potential Effect
The potential effect of SSO2 Therapy is to:

•    restore microvascular flow
•    reduce infarct size to salvage heart muscle.

Results from the AMIHOT I and AMIHOT II clinical studies, sponsored by TherOx, showed a median 26% decrease in infarct size in patients who received SSO2 Therapy following PCI with stenting, vs. a Control group which received PCI with stenting alone.* 30-day MACE comparison (Major Adverse Cardiac Events, including death, reinfarction, target vessel revascularization, and stroke) demonstrated non-inferiority to compared to PCI with stenting alone.**

* Bayesian posterior probability of superiority = 96.9%. Results based on a Bayesian statistical analysis of the AMIHOT I and AMIHOT II clinical studies.

** Bayesian posterior probability of non-inferiority = 99.5% that SSO2 Therapy MACE rate is within 6% of Control group MACE rate.


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What’s the difference between SSO2 Therapy from TherOx and administering an oxygen mask?
An oxygen mask saturates the patient’s blood hemoglobin with oxygen, at a tension of ~150 – 200 mmHg. SSO2 Therapy from TherOx administers 7 times normal oxygen content into the blood plasma – 1,000 mmHg – directly to the area of the heart affected by the heart attack.


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DISCLAIMER

CAUTION: INVESTIGATIONAL DEVICE. LIMITED BY FEDERAL (UNITED STATES) LAW TO INVESTIGATIONAL USE.