How SSO2 Therapy Works
In the TherOx® AO Cartridge, pressurized, hospital-supplied oxygen is dissolved into normal saline. The AO Cartridge continuously draws blood from the patient, using the existing access site for the coronary stenting procedure. 72 ml/min of the patient’s blood is mixed with 3 ml/min of the superoxygenated saline created in the Cartridge, producing 5 –7 X the normal oxygen concentration (760 – 1,000 mmHg) in the blood plasma. This SuperOxygenated blood is then returned directly to the coronary artery via the MI-Cath™ Infusion Catheter*, which is placed just inside the coronary stent. The procedure requires a 5 – 10 minute setup time, and a one-time, 90-minute infusion.
* In Europe, the MI-Cath™ Infusion Catheter is called the AO Catheter.
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.
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 5 – 7 times normal oxygen content into the blood plasma – between 760 – 1,000 mmHg – directly to the area of the heart affected by the heart attack.
DISCLAIMER
Europe: The TherOx® DownStream® System, the TherOx® DownStream® Cartridge, and the TherOx® AO Catheter bear the CE Mark and are available for sale in Europe.
United States: In the United States, the TherOx® DownStream® System, the MI-Cath® Infusion Catheter, and the DownStream® AO Cartridge, are investigational devices. They are limited by United States law to investigational use. They are not for sale or distribution in the United States.
