News | October 15, 2013

Supersaturated Oxygen Therapy to Salvage Myocardium Data Presented at TCT 2013

TherOx will highlight clinical data on first treatment option beyond PCI to salvage heart muscle

October 15, 2013 — TherOx Inc., a medical device company focused on the treatment of Acute Myocardial Infarction (AMI), announced that data will be presented on its Supersaturated Oxygen (SSO2) Therapy at the upcoming 25th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation, on Thursday, October 31. The presentation will include results from the company's multicenter Investigational Device Exemption (IDE) pilot study of a second-generation system that delivers SSO2 Therapy for reduction of infarct size after an AMI.
 
SSO2 Therapy is intended to provide interventional cardiologists with the first treatment option beyond percutaneous coronary intervention (PCI) to salvage heart muscle in heart attack patients. 
 
Although PCI is the standard of care in treating AMI, for many patients it doesn’t do enough to reduce infarct size and achieve maximum clinical benefit. SSO2 Therapy is adjunctive to PCI and is intended to salvage the jeopardized myocardium and thus reduce infarct size by boosting oxygen delivery to the heart muscle immediately after the coronary artery has been opened by PCI. The TherOx system creates SSO2 Therapy by mixing highly oxygenated saline with the patient’s blood and delivers it through a catheter directly to the targeted ischemic area of the heart.
 
TherOx’s SSO2 Therapy received the CE mark and was successful in meeting the safety and effectiveness endpoints in the AMIHOT II trial. Statistical results from the AMIHOT II trial of SSO2 Therapy, together with PCI and stenting, demonstrated a relative reduction of 26 percent in infarct size compared to PCI and stenting alone. In addition, the finding of device effectiveness was supported by additional analyses that showed a 53 percent increased likelihood of having a small (less than 5 percent damage of the left ventricle) infarct among SSO2 Therapy patients. Results were published in Circulation: Cardiovascular Interventions.[1]
 
This second-generation system builds on the success of AMIHOT II and includes the additional benefits of shortening the treatment time to 60 minutes and broadening the treatment area to the entire left coronary system, leaving no ischemic area untreated. SSO2 Therapy is consistent with the 90-minute “door to balloon” initiative and supports the current guidelines for interventional cardiology procedures.
 
For more information: www.therox.com
 
References:
[1] Stone GW, Martin JL, Boer MJ, et al. Effect of Supersaturated Oxygen Delivery on Infarct Size After Percutaneous Coronary Intervention in Acute Myocardial Infarction. Cir Cardiovasc Interv 2009;2:366-75.
 

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